In the next frontier of immuno-oncology competition focusing on treatment around surgery, Bristol Myers Squibb has snatched another U.S. license for Opdivo—this time in bladder cancer.
The FDA has waved through Opdivo for treatment of bladder cancer that’s at high risk of recurrence after radical surgical resection, Bristol Myers said on Friday. This new use isn’t restricted by prior presurgery treatment, lymph node involvement or PD-L1 status, the company added.
The nod marks Opdivo’s third indication in the so-called adjuvant setting, following a 2017 approval in melanoma and a recent go-ahead in esophageal or gastroesophageal junction cancer.
Opdivo, already approved for previously treated metastatic bladder cancer, is now also the first PD-1/L1 drug to target early bladder cancer after surgery. Thanks to an FDA green light in early 2020, Merck & Co.’s rival checkpoint inhibitor Keytruda is allowed to treat superficial but high-risk non-muscle invasive bladder cancer among patients who don’t undergo surgery.
Urothelial carcinoma is the most common type of bladder cancer. Although it can be diagnosed early and treated with surgery, the rates of recurrence and progression remain high at about 50%, Nick Botwood, senior vice president of BMS’s U.S. medical affairs team, explained in a recent interview.
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For this approval, Opdivo won over the FDA with data from the CheckMate-274 trial. Compared with placebo, Opdivo cut the risk to disease recurrence or death by 30% in patients with muscle-invasive bladder cancer. The BMS drug nearly doubled disease-free survival as patients who received it lived a median 20.8 months without recurrence, compared with 10.8 months for the placebo group. The efficacy was more pronounced in patients whose tumors express PD-L1. In that group, Opdivo’s risk reduction on the disease-free survival marker was 45% over placebo.
While there’s currently no standard of care for adjuvant treatment of bladder cancer, doctors will now consider Opdivo given the magnitude of the benefit seen in CheckMate-274, Botwood said.
As Botwood noted, BMS’s Opdivo programs are now moving into earlier stages of cancer. Also in muscle-invasive bladder cancer, the New York pharma is pairing Opdivo with or without partner Nektar Therapeutics’ interleukin-2 drug bempegaldesleukin for both pre-surgical and post-surgical treatment in a phase 3 trial.
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BMS recently touted a first-in-class win for Opdivo in early-stage non-small cell lung cancer. There, the addition of Opdivo to chemotherapy before surgery helped significantly more patients show no signs of cancer in their resected tissue at the point of surgery.
But BMS is not alone in hot pursuit of neoadjuvant and adjuvant indications. In muscle-invasive bladder cancer, Roche recently launched a phase 3 dubbed IMvigor011, evaluating Tecentriq as an adjuvant therapy. Merck’s muscle-invasive bladder cancer trials for Keytruda include pairing with Seagen and Astellas’ antibody-drug conjugate Padcev for both neoadjuvant and adjuvant uses in the Keynote-905 trial, or with neoadjuvant chemotherapy in the Keynote-866 study. But it will be years before those trials read out.