Roche has scored approval from China’s National Medical Products Administration for its PD-L1 inhibitor Tecentriq in small cell lung cancer, solidifying its dominance in the setting.
The fine print of the approval indicates Tecentriq (atezolizumab) for use in combination with chemotherapy (carboplatin and etoposide) for the first-line treatment of patients with extensive-stage SCLC.
Roche’s drug was approved on the back of results from the phase 3 IMpower133 study, in which Tecentriq, in combination with chemo, demonstrated an overall survival rate of 12.3 months in SCLC patients, compared to 10.3 months in the placebo group.
The approval is good news for Roche, as China has a particularly large patient pool – lung cancer is the leading cause of cancer death in the country. SCLC accounts for around 15% of all lung cancer cases, with two-thirds of those diagnosed at the extensive stage of the disease.
“Small cell lung cancer is an area of major unmet need in China and one that has seen limited advances until now,” said Levi Garraway, chief medical officer and head of global product development.
“This approval makes Tecentriq the first cancer immunotherapy available in China for the initial treatment of extensive-stage small cell lung cancer less than a year after the US FDA and EMA approvals, marking a swift and important step forward for patients with this aggressive and difficult-to-treat disease,” he added.
For Roche, SCLC is an important niche for Tecentriq, in a disease area which is otherwise dominated by rival checkpoint inhibitor Keytruda (pembrolizumab), marketed by Merck & Co/MSD.
Keytruda is approved in China for the treatment of non-small cell lung cancer (NSCLC), which is the most common type of lung cancer, accounting for 85% of all new cases. In addition to lung cancer, Merck’s drug is approved for a host of other cancer types, including in China for advanced melanoma.
However, SCLC is one cancer type in which Keytruda does not seem to work – results from the KEYNOTE-604 trial showed that when the drug was added to chemotherapy, it was unable to improve overall survival (OS), despite improving progression-free survival (PFS). OS is considered to be a more robust indicator of the benefit of a cancer drug.
For now, Roche has exclusivity with Tecentriq in the SCLC therapy area, but it could soon face competition from AstraZeneca’s checkpoint inhibitor Imfinzi (durvalumab), which is under review for approval in Europe and the US for SCLC, after it demonstrated a significant improvement in both PFS and OS in the phase 3 CASPIAN trial.