NEW YORK – Roche subsidiary Genentech on Monday said that its PD-L1 inhibitor atezolizumab (Tecentriq) demonstrated promising activity in a Phase III trial as an adjuvant treatment for non-small cell lung cancer, especially in those with PD-L1-expressing tumors.
The company is planning to submit the data from the IMpower010 study to regulatory bodies in the US and in Europe, and present detailed findings at a medical meeting.
The Phase III trial compared atezolizumab against best supportive care in 1,000 NSCLC patients with stage IB to IIIA disease, after they had undergone surgical resection of their tumors and up to four cisplatin-based chemotherapy cycles. Researchers tracked how these treatments impacted disease-free survival in patients with PD-L1-positive, stage II to IIIA tumors; in all randomized patients with stage II to IIIA tumors; and in the intent-to-treat population with stage IB to IIIA tumors.
Genentech will continue to follow patients and conduct its planned disease-free survival analysis in the overall intent-to-treat population, which at the time of the interim analysis had not reached the pre-specified number of events. The company will also track the ability of atezolizumab to extend overall survival, which was not mature at the time of analysis.
Atezolizumab as a single agent and in combination with other drugs is already approved in the US in four metastatic NSCLC indications including in the first-line setting for those with high PD-L1 expression. The interim data from IMpower010 suggests the drug is efficacious in the adjuvant setting as a treatment for early-stage disease and may stave off disease recurrence.
"With these landmark results, Tecentriq has become the first cancer immunotherapy to help many people with resectable early lung cancer live longer without their cancer returning," Levi Garraway, Roche's chief medical officer and head of global product development, said in a statement. "We’re excited by the clinical benefit adjuvant Tecentriq may bring to lung cancer patients, particularly in the PD-L1-positive population. We will submit these data to regulatory authorities as soon as possible."