- Merck KGaA and Pfizer are trumpeting interim clinical results for the combination of Bavencio and Inlyta as first-line treatment of advanced renal cell carcinoma in the Phase 3 JAVELIN Renal 101 study.
- The combo met the study's primary endpoint by significantly outperforming Pfizer's Sutent in improving progression-free survival (PFS) for patients with PD-L1 expression greater than 1%. Bavencio plus Inlyta also beat out Sutent across the study population as a whole.
- Pfizer and Merck KGaA said this is the first positive Phase 3 trial combining an immunotherapeutic and tyrosine kinase inhibitor in any tumor type. The next step will be a regulatory submission in the U.S. and discussions with authorities in other countries.
The PD-1/L1 market, potentially worth $103.4 billion by 2024, has taken off significantly, with Merck & Co's Keytruda (pembrolizumab), Bristol-Myers Squibb's Opdivo (nivolumab), Roche's Tecentriq (atezolizumab) and AstraZeneca's Imfinzi (durvalumab) taking the market by storm.
Merck KGaA and Pfizer's Bavencio (avelumab), meanwhile, is still pretty new to the scene. It only has approvals in Merkel cell carcinoma and bladder cancer, and is still smarting from the failure of a second-line non-small cell lung cancer (NSCLC) study in February 2018.
Yet the fresh renal cell carcinoma data are a bright spot, underscoring "the potential of Bavencio and Inlyta as a new cancer treatment approach for patients," with the disease, according to Chris Boshoff, head of immuno-oncology, early development and translational oncology at Pfizer.
To try to gain ground in the I/O space, the two companies are looking at combo approaches. JAVELIN itself encompasses at least 30 clinical programs, including eight Phase 3 trials and more than 8,600 patients representing at least 15 different tumor types like breast, NSCLC and Hodgkin’s lymphoma.
Recently, the first patient was enrolled in the Phase 3 JAVELIN Ovarian PARP trial. This study combines Bavencio and the experimental PARP inhibitor talazoparib in patients with previously untreated advanced ovarian cancer.
"[The JAVELIN Renal 101 data] support our firm belief in the promise of combining Bavencio with currently approved therapies and novel agents, a strong focus of the overall JAVELIN clinical development program," Luciano Rossetti, global R&D head in the biopharma business of Merck KGaA (which in the U.S. and Canada operates as EMD Serono).
Bavencio has breakthrough therapy designation when paired with Inlyta for treatment-naïve patients with advanced renal cell carcinoma. In about 20-30% of kidney and renal pelvis cancer cases, the cancer cells have spread. The five-year survival rate for these cancers is around 12%, according to the National Institutes of Health.