Big pharma announced phase 3 test results combo of immunotherapy and chemotherapy significantly improved survival vs chemotherapy alone

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For esophageal cancer

 

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https://sg.news.yahoo.com/bristol-myers-squibb-presents-data-210100181.html

 

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https://sg.news.yahoo.com/bristol-myers-squibb-presents-data-210100181.html

Business Wire

Bristol Myers Squibb Presents Data from CheckMate -648 Showing Opdivo plus Chemotherapy and Opdivo plus Yervoy Significantly Improved Overall Survival Compared to Chemotherapy in Unresectable Advanced or Metastatic Esophageal Squamous Cell Carcinoma​

Fri, 4 June 2021, 5:01 AM·41-min read

Opdivo demonstrated significant overall survival benefit over chemotherapy alone in both PD-L1 positive and all-randomized populations in both treatment arms
CheckMate -648 marks the third global trial in which Opdivo demonstrated a significant benefit for patients with upper gastrointestinal cancers
Data to be featured in an oral presentation during the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting

 

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Bristol Myers Squibb (NYSE: BMY) today announced results from the Phase 3 CheckMate -648 trial, in which two Opdivo-based treatment combinations — Opdivo (nivolumab) plus chemotherapy and Opdivo plus Yervoy (ipilimumab) — demonstrated a statistically significant and clinically meaningful overall survival (OS) benefit compared to chemotherapy at the pre-specified interim analysis in patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC) with tumor cell PD-L1 expression ≥1%, as well as in the all-randomized population. Opdivo plus Yervoy is the first dual immunotherapy combination to demonstrate a superior survival benefit versus chemotherapy in this setting. The data will be presented in an oral session on Saturday, June 5, 2021 from 1:45 p.m. to 4:45 p.m. EDT and featured in the official press program during the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting.

 

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For the combination of Opdivo plus chemotherapy, median OS was 15.4 months vs. 9.1 months for chemotherapy in patients whose tumors express PD-L1, a primary endpoint (hazard ratio

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0.54, 99.5% CI: 0.37-0.80, p<0.0001), and 13.2 months vs. 10.7 months in the all-randomized patient population, a secondary endpoint (HR 0.74, 99.1% CI: 0.58-0.96, p=0.0021). A statistically significant progression-free survival (PFS) benefit was also observed with Opdivo plus chemotherapy in patients whose tumors express PD-L1, with a median PFS by blinded independent central review (BICR) of 6.9 months compared to 4.4 months with chemotherapy alone (HR 0.65, 98.5% CI: 0.46-0.92, p=0.0023).

 

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For the combination of Opdivo plus Yervoy, median OS was 13.7 months vs. 9.1 months for chemotherapy in patients whose tumors express PD-L1, a primary endpoint (HR 0.64, 98.6% CI: 0.46-0.90, p=0.001), and 12.8 months vs. 10.7 months, respectively, in the all-randomized patient population, a secondary endpoint (HR 0.78, 98.2% CI: 0.62-0.98, p=0.011). Opdivo plus Yervoy did not meet its other primary endpoint of PFS by BICR in patients whose tumors express PD-L1 (4.0 months vs. 4.4 months; HR 1.02, 98.5% CI: 0.73-1.43, p=0.8958).

 

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The safety profiles of Opdivo plus chemotherapy and Opdivo plus Yervoy were consistent with those previously reported for other tumor types. Grade 3/4 drug-related adverse events were 47% in the Opdivoplus chemotherapy arm, 32% in the Opdivo plus Yervoyarm, and 36% in the chemotherapy arm. The safety profile in patients with PD-L1 ≥1% was consistent with the all-randomized data.

"Patients with advanced esophageal squamous cell carcinoma face a median survival of around 10 months when treated with chemotherapy alone and there is a clear need for treatment options beyond this current standard of care," said Ian Chau, M.D., Consultant Medical Oncologist, The Royal Marsden NHS Foundation Trust. "The data being presented at ASCO show that both of these nivolumab-based treatment options resulted in significant improvements in survival over chemotherapy and could offer potential new treatment options."

 

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CheckMate –648 is the first global Phase 3 study to evaluate both an immunotherapy and chemotherapy combination as well as a dual immunotherapy combination in advanced ESCC.

"These data add to our growing body of evidence supporting the clinical benefit of Opdivo in upper GI cancers, from the late-line metastatic setting to earlier stages of disease," said Ian M. Waxman, M.D., development lead, gastrointestinal cancers, Bristol Myers Squibb. "Opdivo has now demonstrated superior first-line efficacy in multiple upper GI cancers across histologies and tumor locations."

 

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About Esophageal Cancer

Esophageal cancer is the eighth most common cancer and the sixth leading cause of death from cancer worldwide, with approximately 604,000 new cases and over 544,000 deaths in 2020. The two most common types of esophageal cancer are squamous cell carcinoma (ESCC) and adenocarcinoma, which account for approximately 90% and 10% of all esophageal cancers, respectively, though esophageal tumor histology can vary by region. The overall burden of ESCC is concentrated in Asia, where roughly 80% of the global cases occurred in 2020. The majority of esophageal cancer cases are diagnosed in the advanced setting and impact a patient’s daily life, including their ability to eat and drink. ESCC occurs most often in the upper and middle portions of the esophagus, whereas adenocarcinoma begins in the cells of mucus-secreting glands in the esophagus and most often occurs in the lower portion of the esophagus.

 

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After going through cancer treatment, if its slready later stage, your body will be so weak other form of diseases will kill you.

 

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After going through cancer treatment, if its slready later stage, your body will be so weak other form of diseases will kill you.

I am sure there are many takers for cancer treatment if not the big pharma will not go for such trials.

 

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Oh so phase 3 trial is usually up to 3000 patients only.

Phase III of a clinical trial usually involves up to 3,000 participants who have the condition that the new medication is meant to treat. Trials in this phase can last for several years. The purpose of phase III is to evaluate how the new medication works in comparison to existing medications for the same condition.

Clinical Trial Phases: What Happens in Phase 0, I, II, III, and IV​

 

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What happens in phase III?​

Phase III of a clinical trial usually involves up to 3,000 participants who have the condition that the new medication is meant to treat. Trials in this phase can last for several years.

The purpose of phase III is to evaluate how the new medication works in comparison to existing medications for the same condition. To move forward with the trial, investigators need to demonstrate that the medication is at least as safe and effective as existing treatment options.

To do this, investigators use a process called randomization. This involves randomly choosing some participants to receive the new medication and others to receive an existing medication.

Phase III trials are usually double-blind, which means that neither the participant nor the investigator knows which medication the participant is taking. This helps to eliminate bias when interpreting results.

The FDA usually requires a phase III clinical trial before approving a new medication. Due to the larger number of participants and longer duration or phase III, rare and long-term side effects are more likely to show up during this phase.

If investigators demonstrate that the medication is at least as safe and effective as others already on the market, the FDA will usually approve the medication.

 

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The safety profiles of Opdivo plus chemotherapy and Opdivo plus Yervoy were consistent with those previously reported for other tumor types. Grade 3/4 drug-related adverse events were 47% in the Opdivoplus chemotherapy arm, 32% in the Opdivo plus Yervoyarm, and 36% in the chemotherapy arm. The safety profile in patients with PD-L1 ≥1% was consistent with the all-randomized data.

Oh 47% of immunotherapy and chemotherapy combo treatment got severe or life threatening drug related adverse reactions.

https://en.wikipedia.org/wiki/Adverse_event
What are Grade 3/4 adverse events?
Grade 3 Severe AE. Grade 4 Life-threatening or disabling AE. Grade 5 Death related to AE.