Daiichi Sankyo has announced they will be discontinuing a Phase III clinical trial for their lung cancer drug candidate, patritumab. The decision was based on a recommendation from an independent data monitoring committee which found the drug failed to be effective against non-small cell lung cancer.
While the Japanese drugmaker is disappointed in the trial results, it says that it will continue to test the drug’s efficacy as a treatment for head and neck cancers. According to Daiichi Sankyo, the committee identified no safety concerns associated with the drug.
While patritumab made it through a Phase II clinical trial for lung cancer, it failed to meet efficacy goals in the first half of the Phase III study. The drug was assessed on a measure of progression-free survival of patients, with the researchers also investigating whether a protein – called heregulin – could be used as a biomarker for lung cancer.
Daiichi Sankyo currently has three other cancer drugs in its pipeline, and the company was hopeful that patritumab would help it bolster its oncology offerings. As clinical trials for the drug as a therapeutic for head and neck cancer remain in Phase II, the negative results represent a significant setback for the patritumab team.
“We are disappointed that this study did not confirm the hypothesis that effective HER3 inhibition in combination with erlotinib would provide clinically relevant tumor growth control in subjects with advanced non-small cell lung cancer,” said Dr. Antoine Yver, Executive Vice President and Global Head, Oncology Research and Development, Daiichi Sankyo. “Nevertheless, rigorously designed experiments such as Part A of this study in this particular case is at the core of what we do: transform innovative science into value for patients suffering from cancer. The very nature of experiments is to resolve uncertainty and some are bound to not confirm the hypothesis tested.”
In recent years, pharmaceutical companies have been increasingly developing drugs that target specific cancer biomarkers, in an effort to boost their effectiveness. Several new drugs targeting specific mutations involved in non-small cell lung cancer – including Bristol-Myers Squibb’s Opdivo, Eli Lilly’s Portrazza, Merck’s Keytruda and AstraZeneca’s Tagrisso – have been approved in the last few years.
“This particular result does not directly affect the science of patritumab in other settings,” continued Yver. “The phase 2 study evaluating patritumab in head and neck cancer, in combination with cetuximab and a platinum agent, remains unchanged and ongoing. At Daiichi Sankyo we will continue to apply rigorous science to create new hope for patients with cancer.”