October 2, 2022

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Bristol-Myers Squibb OY Combo Bladder Cancer Trial Repeats Mistakes

Bristol-Myers Squibb OY Combo Bladder Cancer Trial Repeats Mistakes



Bristol-Myers Squibb OY Combo Bladder Cancer Trial Repeats Mistakes

On May 16 , Bristol-Myers Squibb announced the Phase III CheckMate-901 trial of Opdivo (nivolumab) plus Yervoy (ipilimumab) in first-line treatment of untreated unresectable or metastatic urothelial carcinoma compared with standard-of-care chemotherapy , the primary endpoint of overall survival (OS) was not met in patients whose tumor cells expressed ≥1% PD-L1 at the final analysis.

The company remains blinded to the data, and an independent data monitoring committee recommended that the trial continue to evaluate other primary and secondary endpoints. No new safety signals were observed at the time of analysis.

Bristol-Myers Squibb OY Combo Bladder Cancer Trial Repeats Mistakes

“Despite some progress in recent years, metastatic urothelial cancer remains an intractable disease with a limited number of life-extending treatment options,” said vice president, genitourinary cancer development program leader, Bristol-Myers Squibb Dana Walker , MD, said, ” Opdivo plus Yervoy has shown durable, long-term survival improvements in several difficult-to-treat advanced cancers, and we are disappointed that the final analysis of CheckMate-901 did not express PD- The same benefit was shown in urothelial cancer patients with L1 ≥ 1% . We remain committed to advancing research in urothelial cancer and we look forward to seeing data from other parts of the CheckMate-901 trial, we thank all involved patients, research personnel and field staff.”

The CheckMate-901 trial is also evaluating Opdivo plus Yervoy in patients with unresectable or metastatic urothelial carcinoma who are not candidates for cisplatin-based chemotherapy.

In addition, a pivotal-intent CheckMate-901 substudy is evaluating Opdivo in combination with chemotherapy versus chemotherapy alone in cisplatin-eligible patients.

The CheckMate-901 main study and sub-studies are ongoing, and the company will report the results of these additional components of the study as they become available.

To date, the Opdivo and Yervoy -based combination has shown significant OS improvements in six phase III clinical trials in five tumors : non-small cell lung cancer, metastatic melanoma, advanced renal cell carcinoma, malignant pleural mesothelioma, and Esophageal squamous cell carcinoma.

In addition, Opdivo has shown clinical benefit in second-line metastatic urothelial carcinoma and auxiliary muscle-invasive urothelial carcinoma.

The Bristol-Myers Squibb OY combination isn’t the only one to suffer setbacks in a newly diagnosed bladder cancer trial.

In 2017 , Merck’s Keytruda received accelerated approval for newly diagnosed bladder cancer patients who were ineligible for cisplatin-based chemotherapy.

The FDA later limited its approval to patients who were ineligible for any platinum-containing chemotherapy, because the independent data monitoring committee of the drug’s confirmatory trial noted that the Keytruda arm performed even worse than the platinum chemotherapy in patients with low PD-L1 expression .

Roche’s PD-L1 inhibitor Tecentriq is also struggling in a confirmatory trial in first-line bladder cancer. This led the FDA to limit its conditional approval to cisplatin-eligible patients with PD-L1 expression covering at least 5% of tumor-infiltrating immune cells and who were ineligible for any platinum-based chemotherapy.

Bristol-Myers Squibb OY Combo Bladder Cancer Trial Repeats Mistakes

(source:internet, reference only)


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