Years after Keytruda, Roche's Tecentriq monotherapy wins first-line NSCLC approval. So does it matter?
Years after Keytruda, patients with previously untreated non-small cell lung cancer (NSCLC) finally have a new checkpoint inhibitor monotherapy option: Roche’s Tecentriq.
Merck’s star drug captured this ripe indication in 2016, winning the battle for checkpoint inhibitor supremacy years ago. On Monday, the FDA approved Roche’s Tecentriq on its own for newly diagnosed, metastatic patients without EGFR or ALK mutations whose tumors carry levels of the biomarker PD-L1 registering at 50% or greater.
The regulatory decision was based on the results of the 572-patient trial, called IMpower110, which tested Tecentriq monotherapy against chemotherapy. (Of course, chemotherapy is no longer the standard-of-care as it was when Roche kicked off the study — it has been displaced by Keytruda, either alone or in tandem with chemotherapy).
Data showed Tecentriq helped patients live longer by an additional 7.1 months compared with chemotherapy: Median overall survival was 20.2 months for patients in the Tecentriq arm compared with 13.1 months in the chemotherapy arm.
“By virtue of being late to market, Tecentriq monotherapy (IMPOWER110) has little chance of gaining significant share in 1L NSCLC despite posting OS similar to Keytruda in PD-L1 high patients,” Cowen analyst Steve Scala wrote in a note earlier this month. “However, that comparable OS benefit may give confidence that any additional efficacy provided by (anti-TIGIT drug) tiragolumab in Phase II will translate to superior performance of the combination in Phase III.”
Lung cancer is the leading cause of cancer death globally, according to the WHO. The two main types of lung cancer are non-small cell and small cell, and NSCLC accounts for about 85% of all cases. The Swiss drugmaker is carving itself a bigger piece of the lucrative immuno-oncology market, which is largely monopolized by Merck’s Keytruda, and to a lesser extent Bristol Myers Squibb’s Opdivo.
This is Tecentriq’s fifth lung cancer approval. The combination of Tecentriq and Avastin is already approved for first-line use in NCSLC patients, offering an option for patients with liver metastases — and it was the first checkpoint inhibitor to secure approval in patients with small-cell lung cancer (SCLC).
Meanwhile, data from a Phase III study unveiled at ASCO recently showed Bristol Myers’ combination of Opdivo and Yervoy cut the risk of death by 31% compared to chemo alone in NSCLC patients.