Roche boosts cancer approvals in Europe, pushing for a bigger slice of the I/O pie
Roche is stacking up approvals for its flagship checkpoint inhibitor in the lucrative field of lung cancer. On Friday, the Swiss drugmaker revealed that the European Commission had endorsed the use of Tecentriq in combination with chemotherapy as the first line of defense in certain patients with advanced non-squamous non-small cell lung cancer (NSCLC).
The approval comes on the basis of the 723-patient IMpower130 study, which tested the drug plus chemo against chemo alone, in patients with stage IV metastatic non-squamous NSCLC, who are not carrying EGFR or ALK mutations.
Data from the study showed the Tecentriq combination helped patients live longer versus chemo alone (median overall survival=18.6 versus 13.9 months; p=0.033). The combo also significantly reduced the risk of disease worsening or death, compared with chemo alone (median PFS=7 versus 5.5 months; p<0.0001).
Roche is pushing for a bigger slice of the lucrative immuno-oncology market, which is already largely divided between leaders Merck $MRK and Bristol-Myers Squibb $BMY. In March, Merck’s keystone Keytruda — in a combo with chemo — scored European approval for frontline use in patients with metastatic squamous NSCLC.
Tecentriq is approved in the United States and the European Union alone and in several combinations with targeted therapies and chemotherapies in certain lung cancers. Months ago, Roche secured the FDA nod in combo with chemo as a first-line treatment for extensive-stage small cell lung cancer (ES-SCLC).
NSCLC accounts for 85% of all lung cancers — within NSCLC, 40% of cases are adenocarcinomas, 25% to 30% are squamous cell carcinomas and 10% to 15% are large cell carcinomas. More than 228,150 Americans will be diagnosed with lung cancer in 2019, and about 142,670 patients will die over the course of the year, estimates the American Cancer Society.
Tecentriq is also approved for certain types of metastatic urothelial cancer, and in PD-L1-positive triple-negative breast cancer. The drug generated sales of about $790 million in the first half of this year.
Roche’s outgoing chief medical officer Sandra Horning added: “Today’s approval marks another advance for people living with non-squamous non-small cell lung cancer, providing a new treatment option for those affected in Europe.” Levi Garraway, formerly at Eli Lilly, takes over from Horning at the end of December.