BASEL, Switzerland—The tail end of summer brought good news to Roche on two cancer fronts, with one Phase 2 study showing the company’s investigational immunotherapy atezolizumab shrank tumors in people with a specific type of lung cancer and another indicating that investigational medicine venetoclax met its primary endpoint in a hard-to-treat type of chronic lymphocytic leukemia.
The first of those was the BIRCH study, and atezolizumab met its primary endpoint and shrank tumors in people with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease expressed programmed death ligand-1 (PD-L1). The study showed the amount of PD-L1 expressed by a person’s cancer correlated with their response to the medicine. Adverse events were consistent with what has been previously observed for atezolizumab.
“We are encouraged by the number of people who responded to atezolizumab and maintained their response during the study, which is particularly meaningful for people who had received several prior treatments,” said Dr. Sandra Horning, chief medical officer and head of global product development for Roche. “We plan to present results at an upcoming medical meeting and will discuss these data as well as results from our other lung cancer studies with health authorities to bring this medicine to patients as quickly as possible.’’
Earlier this year, the U.S. Food and Drug Administration (FDA) granted atezolizumab a Breakthrough Therapy designation for the treatment of people whose NSCLC expresses PD-L1 and who progressed during or after standard treatments (e.g. platinum-based chemotherapy and appropriate targeted therapy for EGFR mutation-positive or ALK-positive disease).
As for the other Phase 2 clinical study, M13-982, it involved venetoclax, an investigational medicine being developed in partnership with AbbVie. The study met its primary endpoint, showing that venetoclax monotherapy resulted in a clinically meaningful reduction in the number of cancer cells in a predefined proportion of people with previously treated (relapsed or refractory) chronic lymphocytic leukemia (CLL) harboring the 17p deletion. No unexpected safety signals were reported for venetoclax.
“Approximately 30 to 50 percent of people with relapsed or refractory chronic lymphocytic leukemia have the 17p deletion that makes their disease difficult to treat,” said Horning. “Venetoclax may help restore the natural process that allows these leukemic cells to self-destruct, representing a potential new way of helping people with this form of CLL who typically have a poor prognosis and limited treatment options.”
Venetoclax was recently granted Breakthrough Therapy designation by the FDA for the treatment of previously treated CLL with the 17p deletion.