Pfizer and EMD Serono are set to scrap the phase 3 JAVELIN Head and Neck 100 study as it was found that avelumab in addition to chemoradiotherapy (CRT) is unlikely to deliver the desired result.
The later stage trial has been evaluating avelumab plus chemoradiotherapy (CRT) in comparison to standard-of-care CRT in patients having untreated locally advanced squamous cell carcinoma of the head and neck (LA SCCHN).
The JAVELIN Head and Neck 100 trial is not expected to yield a statistically significant improvement in the progression-free survival (PFS) based on a preplanned interim analysis with the investigational combination. PFS is the primary endpoint of the phase 3 study, which had enrolled 697 patients.
Secondary endpoints of the trial included overall survival (OS), time to distant metastatic failure, time to locoregional failure, overall response, pathologic complete response, and duration of response.
Pfizer and EMD Serono, the biopharmaceutical business of Merck, have accepted the recommendation of the independent Data Monitoring Committee (DMC) to end the JAVELIN Head and Neck 100 trial owing to the likely result.
Pfizer and Merck had formed a global alliance in late 2014 to jointly develop and commercialise MSB0010718C (presently called avelumab) in a deal worth up to $2.85bn. The anti-PD-L1 antibody was originally developed by Merck as a potential treatment for various types of cancer.
Marketed under the brand name BAVENCIO, the anti-PD-L1 antibody in combination with axitinib has approval in the US for the first-line treatment of patients having advanced renal cell carcinoma (RCC).
In the US, the drug has accelerated approval for the treatment of metastatic merkel cell carcinoma (mMCC) and also in a certain patient population that has locally advanced or metastatic urothelial carcinoma (mUC).
Across 50 countries, avelumab has approval for MCC, with most of these approvals in a broad indication that is not confined to a specific line of treatment.
In preclinical models, the anti-PD-L1 antibody has been shown to engage the adaptive and also the innate immune functions. By preventing the interaction of PD-L1 with PD-1 receptors, avelumab is said to have shown to release the suppression of the T cell-mediated antitumor immune response in preclinical models.