Pfizer and Merck KGaA’s Bavencio threw another Javelin but missed their target in head and neck cancer.
Adding Bavencio to chemoradiotherapy didn’t provide much extra benefit to patients with previously untreated locally advanced squamous cell carcinoma of the head and neck, the pair unveiled Friday.
The independent data monitoring committee found at an interim analysis that the combo wasn’t likely to significantly extend the time to tumor progression or death versus standard-of-care chemoradiotherapy alone. At the experts’ recommendation, the two companies have decided to terminate their phase 3 trial, called Javelin Head and Neck 100.
Pfizer and Merck KGaA aren’t giving up on the PD-L1 med’s potential in head and neck cancer. The alliance is testing Bavencio in different immuno-oncology combinations in the Javelin Medley trial. Investigational drugs the companies are pairing with it include Pfizer’s anti-4-1BB antibody utomilumab and OX40 inhibitor PF-04518600, and on top of them, Checkmate Pharmaceuticals’ TLR9 agonist CMP-001, specifically for head and neck patients.
Currently within the PD-1/L1 class, Merck & Co.’s Keytruda is the only one with an FDA nod in front-line head and neck cancer. Bristol Myers Squibb’s Opdivo is allowed in patients with disease progression on or after platinum-based chemotherapy.
Meanwhile, AstraZeneca’s expected to report findings this year from the phase 3 Kestrel study that combines its PD-L1 Imfinzi with CTLA4 inhibitor tremelimumab in first-line head and neck cancer. AZ is counting on the study after the dual immunotherapy regimen flopped in patients who had already failed on chemo.
As for Roche's Tecentriq, the Swiss drugmaker is running the phase 3 IMvoke010 study to test its potential. The Roche is trying to pitch Tecentriq as an adjuvant therapy used right after definitive local therapy in patients with high-risk head and neck cancer to prevent disease recurrence or progression.
Meanwhile, it's been a bit of a rollercoaster for Bavencio in other indications lately, with the drug recently posting one win and one loss in the clinic. In January, Pfizer and Merck KGaA said Bavencio helped bladder cancer patients whose disease had not progressed after induction chemo live significantly longer compared with best supportive care. It marked the first win for an immuno-oncology agent in that first-line maintenance setting.
However, the maintenance strategy didn’t play out for Bavencio in stomach cancer. After one round of chemo, the med failed to top continuing chemo or best supportive care at extending patients’ lives. The drug failed across the board, as even patients whose tumors tested positive for biomarker PD-L1—who tend to do better than others on PD-1/L1 drugs—didn’t benefit from the therapy.