Roche‘s subsidiary Genentech joined forces with NASDAQ-listed Clovis Oncology to evaluate a novel combination therapy for the treatment of advanced EGFR-mutant non-small cell lung cancer (NSCLC). Its anti PD-L1 cancer immunotherapy and Clovis’ rociletinib will enter Phase Ib/II in 2015.
With 1.35 million new cases annually, lung cancer is the most common cancer worldwide. In 85% of the cases, the lung cancer is known as a non-small cell lung cancer. A part of the patients (between 10 and 30% depending on the region) have a mutation that activates the epidermal growth factor receptor (EGFR). This increases the proliferation of the cancer cells. Several EGFR-inhibitors showing good tumor responses are on the market, but most patients are getting resistant to a second mutation.
This mutation, for which there is currently no treatment, is targeted by Clovis’ rociletinib. Standing alone is received breakthrough designation from the FDA. Clovis submitted market authoritzation application both to FDA and EMA earlier this months.
However, the drug may be even more effective in combination. For this reason, the company partnered with Genentech.
The 35-year-old subsidiary of Roche came off well in this year’s meeting of the American Society of Clinical Oncology, where it presented its Phase II study of its anti-PD-L1 antibody, MPDL3280A. The results showed that the therapy could decrease the risk of death by 53% in certain cancer patients, compared to patients only treated with standard chemotherapy.
Sponsored by Clovis, the combination of MPDL3280A and rociletinib should enter Phase Ib/II before the end of 2015. It is designed to assess safety and activity of the treatment and will be tested in two groups: one with patients who have not previously received an EGFR TKI or chemotherapy, and those who have resistances against a prior EGFR inhibitor.
The combined therapy addresses a critical unmet need. Non-small cell lung cancer is a fast progressing disease that has only a five-year survival rate. Several other big companies are working on a cure, like AstraZeneca and Eli Lilly which are currently testing anti-PD-L1 in combination. This new partnership could help Clovis and Roche to show significative results and help many patients worldwide.