Merck and Pfizer are partnering to run two Phase III trials of avelumab, an immuno-oncology treatment the companies hope to bring to market for a range of cancers.
The giants have an ongoing oncology alliance to trial avelumab, an anti-PD-L1 cancer immunotherapy, in late-stage trials. So far the companies have launched Phase III studies of the drug in people with stage IIIb or IV non-small cell lung cancer (NSCLC), whose disease has progressed after receiving platinum-containing doublet therapy. The alliance is also trialling avelumab in patients with late-stage NSCLC who have not previously received any treatment for their systemic lung cancer.
The latest trials will examine the superiority of avelumab as a maintenance treatment for advanced or metastatic gastric and gastro-esophageal junction cancers, compared to first-line, platinum-based chemotherapy. This study will enroll 629 patients across more than 220 sites in Asia Pacific, Europe, North America and South America.
Another study, of 330 patients worldwide, will evaluate avelumab as a third-line treatment in advanced or metastatic gastric and gastro-esophageal junction cancers.
“The prognosis is generally poor for the majority of patients with advanced gastric cancers,” says Dr Luciano Rossetti, head of global research and development at Merck. “By initiating these two Phase III trials we are continuing the fight against cancer with an overarching goal of potentially improving survival for patients.”
While Dr Mace Rothenberg, senior vice president of clinical development and medical affairs and chief medical officer for Pfizer oncology, says: “We are continuing to investigate avelumab in cancers with high unmet need and where there is a strong rationale for immunotherapeutic intervention.” “Advanced gastric cancer is a challenging diagnosis to face as a patient, and we are dedicating significant resources to evaluate avelumab as a potential new treatment option for patients in multiple settings of this disease.”
Pharmafile.com recently spoke with Keir Woods, head of oncology at Merck UK, on the importance of collaborations in bringing new cancer drugs to market. He said both companies benefitted from the alliance.
“For Merck, it’s our asset, but we are a smaller company so may not have had the capacity to develop avelumab if the partnership wasn’t there. It’s unusual for a company to have a ‘full-blown’ development partnership. But we found there’s a good overlap between Merck and Pfizer; they didn’t have an anti-PD-L1 and they get a targeted immuno-therapy that fits with what is emerging as a second wave of immuno-oncology treatments. We get their scale and their expertise; and a nice pipeline of products behind that.”
Merck KGaA and Pfizer have also agreed to co-market Xalkori (crizotinib), another lung cancer treatment, to combine their efforts in oncology – an agreement Woods says is working well.
“The future seems to be more and more about combination treatments. Part of the deal is for the organisation to collaborate on Xalkori, and we have started that process in the UK, where we have found certain commonalities of culture. In the UK Pfizer’s oncology business unit is quasi-autonomous; this means they can be more flexible and nimble than you would perhaps expect.”