Pfizer/Merck KGaA's Bavencio set for bladder cancer advantage after phase 3 win

Pfizer and German Merck can breathe a sigh of relief after a phase 3 trial confirmed that their immunotherapy Bavencio produces a survival benefit in bladder cancer, when used as a maintenance therapy after a round of chemo.

EMD Serono, the biopharmaceutical division of Germany’s Merck KGaA, said that the phase 3 JAVELIN Bladder 100 study met its primary endpoint of overall survival at the planned interim analysis.

This intensifies a rivalry with Roche's Tecentriq, which has failed to produce a survival benefit in late stage trials but remains on the market, and AstraZeneca's Imfinzi, which the FDA has tentatively approved in bladder cancer based on early data.

The JAVELIN study was testing Bavencio (avelumab) in patients with previously untreated locally advanced or metastatic urothelial carcinoma whose disease did not progress on induction chemotherapy.

Patients who were selected to randomly receive Bavencio plus best supportive care (BSC) lived longer than those who receive BSC only.

A statistically significant improvement in OS was demonstrated in the Bavencio arm in each of the two main populations – all randomised patients and those with PD-L1–positive tumours.

There no surprises in terms of safety, and the companies will submit results at a forthcoming medical congress.

They will also share the results with the FDA as Bavencio was quickly approved on the basis of mid-stage trial results and needs OS results to confirm its US licence.

A latecomer to the cancer immunotherapy market, Bavencio was first approved by the FDA in early 2017 in metastatic merkel cell carcinoma, and in bladder cancer shortly afterwards.

Rivals such as Merck & Co’s Keytruda, Bristol-Myers Squibb’s Opdivo, and Roche’s Tecentriq were already on the market at the time of approval.

A PD-L1 inhibitor, Bavencio has also produced mixed results in clinical trials, falling short in an ovarian cancer trial in late 2018 after also missing the mark in second-line non-small cell lung cancer and third-line advanced stomach cancer.

Chris Boshoff, chief development officer for oncology at Pfizer Global Product Development, said: “Bavencio is the first immunotherapy to demonstrate in a clinical trial a statistically significant improvement in overall survival as a first-line treatment for patients with advanced urothelial carcinoma.

“These latest positive data from the JAVELIN clinical development program add to the body of evidence for BAVENCIO in the treatment of genitourinary cancers, and we look forward to discussing these results with health authorities.”