- Pfizer and Merck KGaA said Monday their immunotherapy Bavencio helped patients with a hard-to-treat type of bladder cancer stay alive longer than those receiving best supportive care.
- The Phase 3 trial result supports a 2017 accelerated approval in metastatic urothelial carcinoma, a cancer type which has proved challenging for other drugmakers that previously received speedy OKs from the Food and Drug Administration.
- Bavencio is now the first immunotherapy to show an improvement in overall survival when given as a first-line maintenance therapy in advanced urothelial carcinoma, Pfizer's chief development officer of oncology Chris Boshoff said in a Jan. 6 statement.
Urothelial carcinoma makes up about 90% of all bladder cancers as well as some kidney cancers. Chemotherapy is typically used first in newly diagnosed patients.
Despite high initial response rates, however, complete remission is rare and cancers usually begin to grow again within nine months, Pfizer and German Merck said in a statement.
The two drugmakers did not release detailed data in their Monday release, beyond saying Bavencio (avelumab) plus best supportive care met the study's primary goal of extending overall survival versus best supportive care alone.
The trial was designed to test whether adding Bavencio could help lengthen survival for patients whose disease had not yet progressed following chemotherapy.
Bavencio's benefit held for all patients enrolled in the study as well as those with tumors positive for PD-L1, a biomarker associated with response to immunotherapy.
PD-L1 is a protein that can be found on the surface of some cancer cells, preventing those cells from being attacked by the body's immune system. Therapies that target this protein, or its counterpart PD-1, have become a leading new type of cancer treatment and include Bavencio as well as Merck & Co.'s Keytruda (pembrolizumab), Bristol-Myers Squibb's Opdivo (nivolumab), Roche's Tecentriq (atezolizumab), AstraZeneca's Imfinzi (durvalumab) and Regeneron's Libtayo (cemiplimab).
While Keytruda and Tecentriq both have accelerated approvals in previously treated urothelial carcinoma, the FDA restricted those OKs in 2018 to only include patients expressing high PD-L1 levels. That decision came from study results showing patients with low levels of that protein were dying sooner than those given chemotherapy.
Bavencio's label does not carry that restriction, and the confirmatory result showing maintenance therapy benefit for all patients could help keep it that way.
Roche in August disclosed Phase 3 data that showed Tecentriq staved off tumor growth in previously untreated patients, but couldn't yet definitively say whether the treatment extended survival.
Recent weeks have also brought other advances in bladder cancer treatment. Seattle Genetics and Astellas recently received an accelerated approval for an antibody drug conjugate called Padcev (enfortumab vedotin) for bladder cancer previously treated with immunotherapy.
And last month, the Blackstone-backed biotech FerGene disclosed Phase 3 results showing its gene therapy helped more than half of patients with a type of non-muscle invasive bladder cancer achieved remission. That gene therapy has been submitted to the FDA for approval.
The positive readout for Bavencio comes about two months since Pfizer and German Merck disclosed a Phase 3 failure for its immunotherapy in gastric cancer. Bavencio is also in late-stage trials for advanced cases of non-small cell lung cancer and squamous cell carcinoma of the head and neck.