- Japanese drugmaker Daiichi Sankyo will stop a phase 3 study of its cancer drug patritumab after an independent data monitoring committee concluded the first half of the study failed to prove efficacy in treating non-small cell lung cancer (NSCLC).
- Daiichi Sankyo said the result, while disappointing, did not "directly affect the science of patritumab," and that it would continue to study the drug against head and neck cancer.
- The first half of the study was designed to confirm whether expression of a protein known as heregulin functioned as a predictive biomarker for the cancer, as well as assess progression-free survival of patients on patritumab.
Despite making it through phase 2 evaluation for NSCLC, patritumab failed to meet pre-defined efficacy goals, Daiichi Sankyo said. There were no safety concerns identified by the monitoring panel.
Daiichi had hoped patritumab would help establish its oncology business, along with three other cancer drugs currently in the pipeline.
The negative interim results will set back patritumab's development, as trials studying the drug against head and neck cancer remain in phase 2.
"This particular result does not directly affect the science of patritumab in other settings. The phase 2 study evaluating patritumab in head and neck cancer, in combination with cetuximab and a platinum agent, remains unchanged and ongoing," said Antoine Yver, head of oncology R&D at Daiichi Sankyo.
Cancer medications are increasingly targeted against specific biomarkers in hopes of boosting response rates for new drugs.
Within the last two years, several drugs have been approved for NSCLC, each targeting specific mutations. Bristol-Myers Squibb's Opdivo and Lilly's Portrazza both target the EFGR mutation, while Merck's Keytruda targets the ALK gene and AstraZeneca's Tagrisso is aimed at the T790M mutation.