#asco conference 2022

[smithhealthcare]

Making Way For Immunotherapy In The GI Cancers, Durvalumab To Become The New Standard of Care For Advanced Biliary Tract Cancers

TOPAZ-1 : Durvalumab Immunotherapy Highlights

Regional subgroup analysis of the Phase III TOPAZ-1 clinical trial of durvalumab (D) plus gemcitabine and cisplatin (GC) in advanced biliary tract cancer (BTC). (Abstract # 4075)

Durvalumab Mechanism of Action: Programmed cell death-1 ligand-1 inhibitors; T lymphocyte stimulants

In the pivotal Phase 3 TOPAZ-1 trial, a prespecified subgroup analysis was performed for efficacy outcomes, including OS for patients enrolled in Asia (China, Hong Kong, India, Japan, South Korea, Taiwan, Thailand) or the rest of the world (RoW; Europe [Bulgaria, France, Italy, Poland, Russia, Turkey, United Kingdom], North America [NA; USA], and South America [SA; Argentina, Chile]).

Patient numbers were balanced across regions (Asia, n=374 [54.6%]; RoW, n=311 [45.4%]). Baseline characteristics were balanced between regions except for modest differences in important pre-defined prognostic factors, including disease status: recurrent disease (Asia 23%; RoW 14.5%), ECOG performance status 1 (Asia 59.1%; RoW 41.2%), and metastatic disease (Asia 89.3%; RoW 82%) suggesting that the study was not adequately powered for the subgroup analyses

More pts in Asia received subsequent anti-cancer therapies in the Placebo arm than patients in RoW (53.6% vs 43.9%). The median duration of follow-up in censored patients was about 2 months longer in Asia versus RoW (14.8 vs 13.0 mo in D + GC; 13.8 vs 12.1 mo in PBO + GC). Regional level analysis showed outcomes were similar and approximated the overall population for Asia, Europe, and NA. Grade 3/4 adverse events were similar for Asia (D + GC 78.5%; PBO + GC 78.6%) and RoW (D + GC 72.7%; PBO + GC 76.7%).

Further results presented on the OS by viral hepatitis status also favored durvalumab + chemotherapy. The mOS for patients with or without hepatitis was 12.6 and 13.2 months, respectively. The placebo results for the same were 11.5 and 10.7, respectively, giving a 20-25% survival benefit to patients treated with durvalumab + chemotherapy arm.

KOL insights

We are hopeful that durvalumab plus gemcitabine and cisplatin will become a new standard of care for advanced BTC. Our first task at this time is boosting communication with patients and family members about the potential for this immunotherapy combination and what it may mean for their ongoing care” –Expert Opinion.

Conclusion

Despite some regional differences in prognostic characteristics, OS trends favored D + GC versus PBO + GC for patients enrolled in both Asia and RoW, supporting the use of D + GC as a potential new treatment option for all patients with advanced BTC.

Companies- AstraZeneca, Puma Biotechnology, Nordic Bioscience, Rafael Pharmaceuticals, Roche, Agios Pharmaceuticals, QED Therapeutics, Delcath Systems, Taiho Oncology, Merck Sharp & Dohme, Ipsen, BeiGene, Celgene, Eisai, Bristol-Myers Squibb, Bayer, Basilea Pharmaceutical.

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About ASCO 2022 Conference Updates

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[reportwire]

ASCO 2022 ahead: Clinical trial updates and data readouts to watch for - MedCity News

ASCO 2022 ahead: Clinical trial updates and data readouts to watch for – MedCity News

  The annual meeting of the American Society of Clinical Oncology kicks off in Chicago this week, the largest and most closely watched of oncology conferences. It also marks a return to an in-person gathering following ASCO’s virtual meetings for the past two years due to Covid-19 (though many of the sessions will also be available online). This year’s conference features more than 2,800…

[medicaltrend]

2022 ASCO: 4 Highlights about Non-Metastatic Non-Small Cell Lung Cancer!

[serhatgumrukcu]

Dr. Serhat Gumrukcu – Inventor of RNA Hijacking Treatment Strategy

Dr. Serhat Gumrukcu, Executive Director and Director of Translational Research at Seraph Research Institute in Los Angeles, California, is known for his breakthrough work on viral diseases like SARS-CoV-2, HIV, HBV, Influenza and many others.

His life-changing research work in infectious and terminal diseases focuses on creating new approaches and mechanisms of action in antiviral therapies for notorious diseases like Ebola and solid tumour cancers.

Life-Changing Works

As a pioneer scientific researcher, Dr. Gumrukcu’s most recent breakthrough is potential prevention and treatment for COVID-19 and influenza using his signature Hijack RNA treatment strategy. The Hijack RNA strategy is a novel mechanism of action, initially invented by Dr. Gumrukcu in 2018 to target dozens of different viruses.

Hijack RNA was shown to be effective against HBV, multiple strains of influenza viruses, and SARS-CoV-2 as well as other coronaviruses, with findings presented at several scientific conferences, including the 2021 Conference on Retroviruses and Opportunistic Infections (CROI)

What is RNA Hijacking?

A virus cannot reproduce without the help of a host cell. However, when the virus finds a host, it can multiply and spread rapidly. The virus replicates and spreads to other cells only after attaching to the host cell and injecting its RNA.

RNA Hijacking tricks the virus into using its machinery to trigger its cells to commit suicide instead of becoming a virus-making factory. These platforms can treat an acute infection or wait in ambush for a cell to be preventing future infections.

After Covid, we have realised the importance of the health care system in the life of human mankind. Researchers like Dr. Gumrukcu have been contributing to human health for a long time and keep doing it now. Breakthrough research like RNA Hijacking is doing us a great favour by showing us light in human health.

Early life

Dr. Serhat Gumrukcu completed his medical study at Dokuz Eylul University in 2004 in Izmir, Turkey. Later, he received his master's degree (M.D.) from I.M. Sechenov Moscow Medical Academy/First Moscow State Medical University.

Then, he did his mandatory two-year residency in Genetics at the same Institution, receiving the Russian equivalent of a PhD (formally recognized as such by the Turkish health and education ministries) for his residency training in genetics. He received another PhD in psychology (unrelated to his former medical practice overseas) from Ankara University in Turkey in 2010 while working on his medical research.

Present Designations

At present, Dr. Serhat Gumrukcu is a member of the American Society of Clinical Oncology (ASCO), International AIDS Society (IAS), HIV Medicine Association (HIVMA), The European Association for the Study of the Liver (EASL), and the American Society of Gene & Cell Therapy (ASGCT) – where he serves on the Cancer Cell & Gene Therapy Committee and the Infectious Diseases and Vaccines Committee. He is also a guest lecturer at UCLA and was recently selected to join the upcoming 2022 JP Morgan Founders Forum bringing together influential leaders worldwide.

[pharmaphorumuk]

Keytruda bags another EU approval in frontline lung cancer

Merck & Co/MSD has tightened its hold on the first-line lung cancer market with another EU approval for Keytruda ��� this time for its use alongside chemotherapy in patients with metastatic squamous non-small cell lung cancer (NSCLC).

The European approval comes after Keytruda was approved for this indication in the US last October, and is great news for patients with squamous forms of NSCLC who have seen treatment advances – and particularly cancer immunotherapies – lag behind other NSCLC subtypes.

Keytruda’s approval in squamous NSCLC comes on the back of the KEYNOTE-407 trial reported at last year’s ASCO meeting, which showed that combining the PD-1 inhibitor with either generic carboplatin or nab-paclitaxel, the active ingredient in Celgene’s Abraxane and various generic rivals in Europe, improved overall survival.

Many patients with advanced squamous NSCLC are still being treated with chemotherapy, although Keytruda has been approved as a monotherapy for patients with PD-L1-expressing squamous tumours since 2015.

The all-comer approval for the combination regimen extends the number of squamous NSCLC patients eligible for treatment with Keytruda, and consolidates its already-dominant position in first-line NSCLC that allowed it to overtake arch-rival Opdivo (nivolumab) from Bristol-Myers Squibb in sales terms last year.

Squamous NSCLC is less common than non-squamous forms but still accounts for around a third of all cases and is notoriously hard to treat. The combination approval promises to usher in a new standard-of-care for patients, with Keytruda monotherapy still an option for patients too ill to handle chemotherapy.

“Lung cancer is the leading cause of cancer death in Europe, so this approval marks an important milestone for the patients and families facing this difficult-to-treat type of lung cancer,” commented Dr Luis Paz-Ares of the Hospital Universitario Doce de Octubre in Madrid, Spain, who was one of the principal investigators in KEYNOTE-407.

The approval is another boost for Celgene’s Abraxane, which has benefited from a string of new licenses in combination with immuno-oncology drugs in the last few months, including a green light in the US alongside Roche’s Tecentriq (atezolizumab) in triple-negative breast cancer a few days ago.

Abraxane is however facing generic competition in Europe having lost patent protection last year, although Celgene is claiming market exclusivity in the US until at least 2022.

Roche also has eyes on the first-line squamous NSCLC market, and at ASCO in 2018 reported interim results from the IMpower131 study of Tecentriq plus chemotherapy in this setting.

That revealed a benefit for the combination versus chemotherapy alone in progression-free survival (PFS), but failed to show any improvement in overall survival at ASCO. It missed the mark on that measure once again in an update presented at the ESMO conference last October, handing the advantage to Keytruda for the time being.

The post Keytruda bags another EU approval in frontline lung cancer appeared first on Pharmaphorum.

from Pharmaphorum https://pharmaphorum.com/news/keytruda-eu-approval-lung-cancer/

[smithhealthcare]

[smithhealthcare]

Pfizer Presents First Data from Planned Interim Analysis of Pivotal Phase II MagnetisMM-3 Trial of BCMA-CD3 Bispecific Antibody Elranatamab (PF-06863135)

Mechanism of Action: Binds BCMA on myeloma cells and CD3 T cells, thereby bringing together T cells and activating them in the vicinity of the myeloma cell resulting in cell kill.

Main Content- Elranatamab is a BCMA x CD3-targeted investigational therapy currently being developed to treat multiple myeloma. The agent has been granted fast track designation by the United States Food and Drug Administration (FDA). Pfizer presented findings of Elranatamab’s Phase II MagnetisMM-3 study (NCT04649359) at ASCO 2022. MagnetisMM-3 is a Phase II open-label, multicenter, single-arm trial examining the safety and efficacy of elranatamab monotherapy in patients with relapsed/refractory multiple myeloma.

Initial efficacy findings of elranatamab showed a 60.6% objective response rate after a median follow-up of 3.71 months. At the time of the data cut-off, 89.5% of objective responders were ongoing with no evidence of progression or death.

The safety and effectiveness of 94 patients who had received at least one dose of elranatamab (Cohort A – BCMA- naïve) as of the data cutoff on March 23, 2022, were studied in this interim analysis. In patients with triple-class refractory Multiple Myeloma, the data revealed that 76 mg of elranatamab weekly (QW) might have a tolerable safety profile. Hematologic adverse events such as anemia, neutropenia, thrombocytopenia, lymphopenia, and cytokine release syndrome (CRS) were the most prevalent treatment-emergent adverse events. All CRS were Grade I (40.0%) or II (40.0%) in the 90 individuals who underwent the 2-step-up priming regimen (18.9%). In addition, ICANS (immune effector cell-associated neurotoxicity syndrome) affected 2.2% of patients, all of whom were in Grade 2 or below.

“Bispecific antibodies hold promise as the next breakthrough in treating multiple myeloma. These data represent an important step forward as we look to bring elranatamab as a potential innovative new treatment to people living with relapsed or refractory multiple myeloma, where there is a high need”-Expert Opinion.

“We are encouraged by these early efficacy and safety results, which suggest elranatamab may have a manageable safety profile coupled with early promising clinical responses. We look forward to the final analysis from MagnetisMM-3, which is expected later this year.” -Expert Opinion.

Conclusion: The antibody-drug conjugate (Blenrep) and the FDA-approved CAR T-cell therapies (Abecma and Carvykti) are the current BCMA-directed choices for heavily pretreated Multiple Myeloma patients. In the registrational directed Phase II MagnetisMM-3 trial, Pfizer's BCMA x CD3 bispecific antibody elranatamab demonstrated encouraging preliminary effectiveness and tolerability. Before this, the company disclosed results from the phase I MagnetisMM-1 study (NCT03269136), which demonstrated that when elranatamab was administered in dosages up to 1000 µg/kg, the drug had a tolerable safety profile with no dose-limiting toxicities (DLT’s) when presented at the 2021 ASCO Annual Meeting. It is worth noting that the FDA slapped a partial clinical hold on the drug last year owing to peripheral neuropathy cases. But now, the hold has been lifted.

Along with Pfizer, many companies, including J&J, Roche, Regeneron Pharmaceuticals, and others, are investigating bispecific antibodies in Multiple Myeloma. Some of the companies are investigating non-BCMA targets, including FcRH5 and GPRC5D. J&J holds the lead among many bispecific antibodies being explored for Multiple Myeloma. Janssen's teclistamab is the first BCMA x CD3 bispecific to be filed to the FDA (filing in December 2021) and EMA (filing in January 2022) for approval in Multiple Myeloma. While teclistamab appears to be on track to become the first BCMA-targeting bispecific antibody to hit the market, Pfizer's elranatamab is closely following J&J's footsteps. In the registration MagnetisMM-3 trial, elranatamab was linked with an ORR of 60.6 percent after a median follow-up of just under four months; on the other hand, teclistamab's MajesTEC-1 study gave an ORR of 63%. Pfizer’s therapy has a competitive edge in terms of safety profile. The MagnetisMM-3 data show a 60% rate of CRS, compared to roughly 72% in the teclistamab trial. Because bispecific antibodies are off-the-shelf, readily available medicines, they are anticipated to become widely employed in the relapsed/refractory arena. In this area, ADC and CAR T-cell therapies are already available, but the inclusion of bispecific antibodies may provide patients with more options (different treatments will be appropriate for different patients).

Companies- Oncopeptides, GlaxoSmithKline, Bluebird Bio, Janssen Pharmaceutical, Legend Biotech, AbbVie, Roche (Genentech), Bristol Myers Squibb, Regeneron Pharmaceuticals, Pfizer, Takeda, Amgen, SpringWorks Therapeutics, Arcellx, Gracell Biotechnologies, Oricell, Poseida Therapeutics, Precision Biosciences, CRISPR Therapeutics AG, Collectis SA, Allogene Therapeutics, Fortis Therapeutics, Novartis, I-Mab/MorphoSys, Cartesian Therapeutics, CASI Pharmaceuticals, LAVA Therapeutics, and others.

To Get a Detailed analysis of ASCO Conference 2022 Abstracts, Visit: ASCO 2022 Detailed Coverage | ASCO 2022 Conference | ASCO Conference 2022 | ASCO Abstract 2022

Some of the Latest ASCO Abstract 2022 Launched:-

·        Can Breyanzi be a hit CAR-T in second-line treatment after failing in the first-line setting for the patients with R/R Large B-cell lymphoma (LBCL)?

·        Teclistamab, a soon-to-be-approved bispecific antibody, demonstrates its promise in Multiple Myeloma during ASCO 2022.

·        Merus’ Zenocutuzumab, a HER2-HER3 Bispecific Antibody, Successfully Targets NRG1 Fusions in Lung and Pancreatic Cancer

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[smithhealthcare]

Sanofi’s ADC is targeting CEACAM5 in patients with NSCLC. CEACAM5 is expressed in 20% of patients with NSCLC Adenocarcinoma

Phase I/II study of tusamitamab ravtansine (Sanofi) in patients with non-sq having locally advanced or metastatic NSCLC for which no standard alternative therapy is available.

Tusamitamab ravtansine (SAR408701) is an ADC composed of a humanized monoclonal antibody that binds carcinoembryonic antigen-related cell adhesion molecule-5 (CEACAM5) and a cytotoxic maytansinoid that selectively targets CEACAM5-expressing tumor cells.

A total of 24 patients were treated for ≥ 6 months, 15 patients for ≥ 9 months, 11 patients for ≥ 12 months, 6 patients for ≥ 24 months, and 2 patients for ≥ 42 months. At the data cutoff, 5 patients remained on treatment, 1 for > 3.5 y. For patients treated ≥ 12 months, the median treatment duration was 26.6 months.

Of 15 patients with PR in the prior analysis, as of Dec 2021, PR was still observed in 10 patients (67%) treated for ≥ 6 months, 8 patients (53%) for ≥ 9 months, and 7 patients (47%) for ≥ 12 months. For the 11 patients treated ≥ 12 months, 7 had PR, and 4 had SD. Of the 11 patients treated ≥ 12 months, 9 had high CEACAM5 expression, and 2 had moderate CEACAM5 expression; most had prior treatment with an anti-PD1/PD-L1.

Patients treated for ≥ 12 months had better ECOG performance status and fewer prior treatments than the overall group. Of patients treated for ≥ 12 months, PR occurred irrespective of CEACAM5 expression level. Only 1 patient treated for ≥ 12 months discontinued due to a treatment-emergent adverse event (TEAE). Corneal events (keratitis/keratopathy) were the most frequent TEAEs.

KOL insights

“The observed long-term clinical benefit and safety profile of Tusa support its further clinical development; a Phase III study is ongoing to evaluate Tusa monotherapy in previously treated pts with high CEACAM5 expressing NSQ NSCLC”–Expert Opinion.

Conclusion

CEACAM5 is expressed in about 20% of patients with NSCLC adenocarcinoma but is not found in normal lung tissue. This makes CEACAM5 a potentially attractive therapeutic target; therefore, it is currently being explored as a potential biomarker. Understanding CEACAM5 may potentially give us more insights to target this malignancy with a poor prognosis.

Until now, Tusamitamab ravtansine clinical trial results have been most promising in NSQ-NSCLC; in fact, it is the most advanced novel agent in clinical testing targeting CEACAM5, specifically NSLC patients. The ADC has already entered phase III development for NSCLC; moreover, it is also being evaluated in Phase II trials for Metastatic Breast and Pancreatic Cancer.

To Get a Detailed analysis of ASCO Conference 2022 Abstracts, Visit: ASCO 2022 Detailed Coverage | ASCO 2022 Conference | ASCO Conference 2022 | ASCO Abstract 2022

Some of the Latest ASCO Abstract 2022 Launched:-

Can Breyanzi be a hit CAR-T in second-line treatment after failing in the first-line setting for the patients with R/R Large B-cell lymphoma (LBCL)?

Teclistamab, a soon-to-be-approved bispecific antibody, demonstrates its promise in Multiple Myeloma during ASCO 2022.

Merus’ Zenocutuzumab, a HER2-HER3 Bispecific Antibody, Successfully Targets NRG1 Fusions in Lung and Pancreatic Cancer

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[smithhealthcare]

Takeda’s Flagship Product Panitumumab (PAN)+mFOLFOX6 Versus bevacizumab (BEV) + mFOLFOX6

Panitumumab (PAN) + mFOLFOX6 Versus Bevacizumab

Patients in the Takeda-sponsored Phase III research comparing PAN + mFOLFOX6 to BEV + mFOLFOX6 as the first-line treatment for metastatic colorectal cancer (mCRC) (mCRC) (LBA1 abstract)

A completely human monoclonal antibody called panitumumab targets the epidermal growth factor receptor (EGFR). In 2019, the US FDA and the EMA approved panitumumab for the treatment of RAS wild-type metastatic colorectal cancer (mCRC) in combination with FOLFOX (5-fluorouracil, leucovorin, and oxaliplatin) or FOLFIRI (5-fluorouracil, leucovorin, and irinotecan) in the first-line setting, in combination with FOLFIRI in the second-line setting.

At a median follow-up of 61 months in the PARADIGM trial, panitumumab significantly improved OS in both the population with left-sided malignancies and the entire study population. With panitumumab, the median PFS for the entire population was 12.9 months as opposed to 12 months with bevacizumab. In the group with left-sided tumors, the stratified hazard ratio (HR) for mortality with panitumumab compared with bevacizumab was 0.82 (P =.031) and 0.84 (P =.030) in the complete analytic population. The group with left-sided tumors had median OS lengths of 37.9 months in the panitumumab arm and 34.3 months in the bevacizumab arm; however, the mPFS duration was not substantially different (13.7 vs. 13.2). The Response Rate, however, also supported panitumumab (80.2%).

KOL insights

According to Expert Opinion, "These data support the first-line use of panitumumab plus modified FOLFOX6 in patients with RAS wild-type and left-sided metastatic colorectal cancer."

Conclusion

Modified FOLFOX6 (mFOLFOX6) plus panitumumab significantly improved overall survival (OS) in patients with wild-type RAS metastatic colorectal cancer (mCRC) who had left-sided tumors when compared to mFOLFOX6 plus bevacizumab. No new safety signs were noticed, according to the study's researchers. The trial showed superiority with panitumumab over bevacizumab in combination with mFOLFOX6, they added. This was true for both left-sided tumors and the total mCRC populations.

Companies- Mirati Therapeutics, Merck Sharp & Dohme, Pfizer, Ono Pharmaceutical, G1 Therapeutics, Daiichi Sankyo, AstraZeneca, and others.

Also, read- ASCO Conference 2020 | ASCO 2020 Abstracts | ASCO 2021 Highlights

ASCO Medical Conference | ASCO 2021 | ASCO 2021 Conference | when in ASCO 2021 | 2021 ASCO | ASCO US | ASCO 2022 Annual Meeting | ASCO Abstract 2022 |

ASCO 2021 Abstracts

[smithhealthcare]

AbbVie’s Telisotuzumab Vedotin (Teliso-V) Demonstrated Encouraging Responses In C-MET NSCLC Patients Who Progressed On Previous Treatments

Phase II study of telisotuzumab vedotin in patients with c–MET+ NSCLC who have previously received not more than 2 lines prior systemic therapy (Abstract # 9016)

An anti-c-MET antibody-drug conjugate (ADC) called telisotuzumab vedotin is made up of a monoclonal antibody attached to monomethyl auristatin E. (MMAE). In the Phase I Study (MN14-237), Teliso-V and osimertinib are given to patients with previously treated NSCLC who have c-MET overexpression. Recently, the FDA granted the medication Breakthrough Therapy Designation (BTD) for use as monotherapy in patients with metastatic or advanced EGFR-wt non-squamous NSCLC whose cancer has progressed or grown after receiving platinum-based therapy.

Results of patients treated with Teliso-V and osimertinib in Phase I/Ib who had EGFR L858R, ex 19 deletions, and overexpression of c-MET. An ORR of 58 percent was seen when Teliso-V and osimertinib were combined. According to its recommended dosage, Teliso-V had an ORR of 3 (43%) out of 7 patients receiving 1.6 mg/kg and 8 (67%) out of 12 patients receiving 1.9 mg/kg.

A preliminary analysis from the Phase II LUMINOSITY trial, which involved 136 patients and of whom 122 could be evaluated for the main outcome, was given by AbbVie. The objective response rate (ORR) as determined by an impartial central review served as the primary endpoint. The Bayesian model predicts that stage 2 advancement is more likely if at least 70% of the genuine ORR is present. 131 (96%) of patients experienced treatment-emergent adverse events (TEAEs) of any grade, and 65 patients experienced Grade 3+ adverse events (48 percent of patients).

KOL insights

“Patients with NSCLC have a high unmet need, and telisotuzumab vedotin has the potential to provide them with an additional treatment option to manage their disease.”–Expert Opinion.

Conclusion

The effectiveness of both cytotoxic chemotherapy and targeted therapy is affected by the anti-cancer treatment class known as antibody-drug conjugates (ADCs), which can deliver cytotoxic medications directly to tumour cells. The use of ADCs is expanding quickly, and early research in lung cancer has produced encouraging results. ADCs that target HER2, HER3, TROP2, CEACAM5, and MET are now being tested in clinical studies for NSCLC.

Oncogene tyrosine kinase receptor (c-MET) is the term used to describe this substance. Numerous cellular processes can be regulated by c-MET, and when these processes are dysregulated, tumour cells are more likely to proliferate, survive, invade, and spread. Point mutations, amplification, fusion, and protein overexpression are c-MET changes found in NSCLC that are linked to a poor prognosis.

MET activation has previously been implicated as both a primary oncogenic driver mutation and a secondary driver of acquired resistance to targeted therapy in other genomic subpopulations, according to preclinical and clinical investigations. Agents that target c-MET are thus a possible therapeutic approach for NSCLC. There isn't currently a targeted medication that specifically targets NSCLC with c-MET overexpression. Therefore, obtaining a BTD can be essential in securing approval for the primary therapy in this patient group by providing this chemical.

Companies- Janssen, Cullinan Oncology, Immutep, Bristol Myers Squibb, Merck Sharp & Dohme, Surface Oncology, AbbVie, Daiichi Sankyo, Chugai Pharmaceutical, Regeneron, Sanofi, and others.

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[smithhealthcare]

Is Paxalisib Better Than Temozolomide In The First-Line Setting?

Paxalisib better than Temozolomide?

Paxalisib's mechanism of action involves directly suppressing PI3K in the PI3K/AKT kinase (also known as protein kinase B) signalling pathway, which prevents the PI3K signalling pathway from being activated. In sensitive tumour cell populations, this may prevent both cell growth and survival.

When used as first-line therapy in individuals with glioblastoma, paxalisib Phase II results from Kazia Therapeutics are comprehensive and contain interesting sensitivity analysis. In this single-arm research, paxalisib was administered as monotherapy to all 30 evaluable patients with newly diagnosed glioblastoma with unmethylated MGMT promotor status. According to the study, temozolomide had a median overall survival of 15.7 months while the median overall survival for patients who had previously received treatment was 12.7 months. Furthermore, according to the RANO criteria, the median progression-free survival (mPFS) was 8.6 months, a significant improvement above the 5.3 months linked to temozolomide. Kazia Therapeutics' profile paxalisib (safety) was quite consistent with earlier clinical investigations.

The updated data, which was presented at ASCO today, "provides a more comprehensive view of the trial and also includes some useful sensitivity assessments." - Expert Verdict.

Conclusion

With regard to newly diagnosed glioblastoma patients, paxalisib anticipates a dramatic shift in the therapeutic paradigm given the encouraging results of its Phase II data. But let's not lose sight of the fact that GBM is a very tough nut to crack given the aggressiveness of the illness and the dismal survival rate. Bevacizumab has been approved for recurrent GBM patients for years, however it has not been successful in first-line GBM treatment (except in Japan). However, paxalisib looks to provide better hope for safety and tolerability in patients with recently diagnosed glioblastoma.

The GBM market is currently experiencing some activity in the ASCO 2022, with SurVaxM (MimiVax) demonstrating promising results and paxalisib now demonstrating its promise in the first-line context. Other important GBM treatments, including Regorafenib (Bayer), Durvalumab (MEDIMMUNE/AstraZeneca), and ONC-201, are in development (Chimerix).

Newly Diagnosed Glioblastoma Companies- Aivita Biomedical, Inc., Inovio Pharmaceuticals, Denovo Biopharma, IMVAX, Merck Sharp & Dohme Corp. and Eisai, MimiVax, Bristol-Myers Squibb, Novartis Pharmaceuticals.

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asco 2021 highlights | asco highlights 2021 | asco medical conference | asco 2021 | asco 2021 conference | when is asco 2021 | 2021 asco | 2021 asco annual meeting | asco convention | asco conference 2021 | asco 2021 | asco 21 | asco us | asco 2022 annual meeting | asco abstract 2022

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[smithhealthcare]

With The Emergence of Next-Generation SERDs, Sanofi Might Hit The Mark

Amcenestrant or letrozole's pharmacodynamic (PD) activity in postmenopausal individuals with ER+/HER2 primary breast cancer will be evaluated in the AMEERA-4 preoperative window-of-opportunity investigation.

Regardless of the baseline (BL) ESR1 mutation status, amcenestrant (Sanofi), an optimised oral selective ER degrader (SERD) that antagonises and degrades the ER, has shown promising early safety and anticancer effectiveness in postmenopausal patients with metastatic breast cancer that is ER+/HER2 positive. The AMEERA-4 (NCT04191382) is a Phase II preoperative window-of-opportunity research that used paired biopsies to analyse biomarkers to assess the PD activity of two dose levels of amcenestrant or letrozole. No formal statistical comparisons were made because trial enrolment in AMEERA-4 was voluntarily ended early when useful evidence supporting adjuvant development became available.

95 of the 105 randomly assigned patients (amcenestrant 400 mg, amcenestrant 200 mg, and letrozole) received treatment, and pre- and post-treatment Ki67 data were available, according to a central evaluation. The features of the BL patient and tumour were not significantly out of equilibrium. The geometric least squares means (LSM) estimate of the Ki67 reduction for amcenestrant 400 mg, amcenestrant 200 mg, and letrozole was 75.9%, 68.2%, and 77.7%, respectively.

In terms of safety, letrozole had a TRAE incidence of 25.7 percent, amcenestrant 400 mg had a TRAE incidence of 21.2 percent, and amcenestrant 200 mg had a TRAE incidence of 22.2 percent.

Conclusion

The 200 mg QD dose of amcenestrant was chosen for our ongoing investigation in the adjuvant context; AMEERA-6; based on PD activity and safety, emerging findings from AMEERA-4, and other ongoing amcenestrant clinical trials (NCT05128773). Sanofi aims to move quickly and make amcenestrant the first SERD in the adjuvant context, as evidenced by the failure of AMEERA-3 and its decision to stop the AMEERA-4 investigation midway through while beginning the AMEERA-6 research in the bigger adjuvant setting pools.

Roche and Eli Lilly are also testing their SERDs in the adjuvant context, joining Amcenestrant in the competition. A broad promise for this patient population in combination and as monotherapy has been shown by the advent of numerous novel selective oestrogen receptor degraders (SERDs) in the ESR1 region. Additionally, the early.

Breast Cancer Companies- Gilead, Sanofi, AstraZeneca, Eli Lilly, Radius Health, Sermonix Pharmaceuticals, Roche, Veru Pharma, and others.

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[smithhealthcare]

Performance of Veru Pharma’s Sabizabulin in Phase I/II mCRPC trial. Phase III VERACITY trial has already Commenced

In the Phase Ib/II clinical trial of Sabizabulin in men with metastatic castration-resistant prostate cancer, Veru published important findings.

Sabizabulin Mechanism of Action: Tubulin inhibitors; Tubulin polymerization inhibitors

The alpha and beta-tubulin subunits of cellular intermediate filaments and microtubules are targeted, bound, and crosslinked by the first-in-class small chemical sabizabulin, disrupting the cytoskeleton. Additionally, sabizabulin kills cells by cleaving poly ADP ribose polymerase (PARP), a crucial enzyme for cancer cells' DNA repair.

The results reported at the ASCO 2022 Conference was fairly substantial in terms of the drug's efficacy, attaining a total response rate of 20.7 percent for all patients who have taken at least a 63mg dose. Additionally, 11.4 months were the median radiographic progression-free survival. Sabizabulin dosage was well tolerated in terms of safety, and there were no clinically relevant reports of neurotoxicity or neutropenia. The Phase III VERACITY trial of sabizabulin for men with metastatic castration-resistant prostate cancer (mCRPC) who have progressed on an androgen receptor targeted drug was also started because of these data, which is significant.

"The Phase 1b/2 study of the sabizabulin clinical trial demonstrated a significant 11.4 months median radiographic progression-free survival in patients with metastatic castration-resistant prostate cancer that has progressed while receiving an androgen receptor targeting agent," according to the study. - Professional View.

Conclusion

Given the encouraging results of the sabizabulin ASCO 2022, we may assume that these preliminary data showed that the medicine looks to be very active in these individuals and has the potential to address a critical unmet medical need. Since the launch of docetaxel and the subsequent findings from clinical trials of novel hormonal drugs, such as abiraterone and enzalutamide, the therapeutic options for mCRPC have undergone significant evolution. A median progression-free survival of 3 to 4 months is frequently the starting point for other treatments used in these patients, such as docetaxel chemotherapy or other androgen targeting medicines.

In light of these results, it may be concluded that sabizabulin appears to be fairly active in these patients and that continued oral therapy with a favourable safety profile is feasible. Moving on to the CRPC market, which is already very crowded, there is a lot of rivalry going on between the new medications, so the medication needs to have a respectable safety profile and greater efficacy to earn their valued place in the market. Sabizabulin is an exciting first-in-class medicine that could be added to the therapy arsenal for mCRPC, based on the scenario for the drug.

A few rivals, including Roche, Modra Pharmaceuticals, Candel Therapeutics, Eli Lilly, Pfizer, Janssen, Clovis Oncology, Bristol-Myers Squibb, AstraZeneca, Janssen Research & Development, and others, are also assessing their lead candidates for CRPC at various levels of clinical development.

To Get a Detailed analysis of ASCO Conference 2022 Abstracts, Visit: ASCO 2022 Detailed Coverage | ASCO 2022 Conference | ASCO Conference 2022 | ASCO Abstract 2022

Some of the Latest ASCO Abstract 2022 Launched:

Can Breyanzi be a hit CAR-T in second-line treatment after failing in the first-line setting for the patients with R/R Large B-cell lymphoma (LBCL)?

Teclistamab, a soon-to-be-approved bispecific antibody, demonstrates its promise in Multiple Myeloma during ASCO 2022.

Merus’ Zenocutuzumab, a HER2-HER3 Bispecific Antibody, Successfully Targets NRG1 Fusions in Lung and Pancreatic Cancer

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[smithhealthcare]

Is GSK's Jemperli giving us reason to believe that cancer can be beaten? It's incredible to have a response rate of 100%

Every Patient in a Drug Trial Has Their Rectal Cancer Disappear

In mismatch repair-deficient locally advanced rectal cancer, single-agent PD-1 blocking as a curative-intent treatment

A total of 30 patients with clinical stage II and III dMMR rectal cancer will be enrolled in the single-arm Phase II study of dostarlimab. T3 or T4 rectal tumors are found in 78 percent of the 18 individuals who have been included so far. The tumours in all of the patients were dMMR and BRAF V600E wild-type, with a mean mutational burden of 67.

Patients in the study were given 500 mg of the PD-1 monoclonal antibody dostarlimab intravenously every three weeks for six months, for a total of nine cycles. The average length of follow-up for the study was 6.8 months, however four patients were followed for nearly two years, and only four patients received less than the needed six months of treatment.

At 6 months, the majority of the patients had a clinical complete response (cCR), but some had it at 3 months as well. There were no grade 3 or 4 adverse events detected in terms of safety. PD-1 inhibition may be able to substitute chemotherapy, chemotherapy plus radiation therapy, or chemotherapy, radiation, and surgery in dMMR rectal cancer. According to the findings, the third option may become a reality.

"For patients with stage II/III dMMR colorectal cancer, neoadjuvant dostarlimab for 6 months represents a promising novel treatment [and] bigger multicenter clinical studies with longer follow-up and disease-free survival and overall survival outcomes are needed." Identification of prognostic indicators of pathologic full response will be crucial in guiding treatment for our patients." - Professional Opinion.

Conclusion

Adult patients with mismatch repair deficient (dMMR) recurrent or advanced solid tumours who have progressed on or following prior therapy and have no viable therapeutic options obtained accelerated Jemperli FDA approval. Approximately 5% to 10% of rectal tumours are dMMR-positive, meaning they are resistant to chemotherapy.

The medicine has shown unprecedented outcomes, and we should note that the majority of patients had large, bulky tumours, with 94 percent of them being node-positive. Furthermore, no patient required chemotherapy, radiation, or surgery after the treatment, and there have been no illness recurrences to date.

Hutchison Medipharma (fruquintinib), Isofol Medical (arfolitixorin), Sumitomo Dainippon Pharma (napabucasin/BBI-608), G1 Therapeutics (trilaciclib + Chemotherapy), Merck (Olaparib Bevacizumab), and AB Science (masitinib + Chemotherapy) are among the pharmaceutical companies with products in the late stages of clinical development.

To Get a Detailed analysis of ASCO Conference 2022 Abstracts, Visit: ASCO 2022 Detailed Coverage | ASCO 2022 Conference | ASCO Conference 2022 | ASCO Abstract 2022

Some of the Latest ASCO Abstract 2022 Launched:

Can Breyanzi be a hit CAR-T in second-line treatment after failing in the first-line setting for the patients with R/R Large B-cell lymphoma (LBCL)?

Teclistamab, a soon-to-be-approved bispecific antibody, demonstrates its promise in Multiple Myeloma during ASCO 2022.

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