Health Canada and European Commission OK Tecentriq-Chemo Combo for Aggressive Lung Cancer

Health Canada and the European Commission have approved Tecentriq (atezolizumab) in combination with chemotherapy (carboplatin plus etoposide) as a first-line treatment for patients with extensive-stage small cell lung cancer (ES-SCLC), an aggressive form of lung cancer.

Tecentriq is an immune checkpoint inhibitor developed and marketed by Genentech, a Roche subsidiary, that has been approved by the U.S. Food and Drug Administration (FDA) and the European Commission to treat certain types of cancer, including bladder and metastatic non-small cell lung cancer (NSCLC).

In May, the FDA approved Tecentriq in combination with chemotherapy for treating patients with ES-SCLC in the U.S. A few months later — Health Canada in August, and then the European Commission in September — also approved the combo therapy for the same indication in Canada and Europe.

“The unmet need in small cell lung cancer is very high as the majority of patients are diagnosed at a late stage,” Shem Singh, executive director of Lung Cancer Canada, said in a press release. “New treatment options are needed and the approval of atezolizumab provides a new tool for Canadians living with small cell lung cancer to manage the disease and spend more time with their families.”

“This approval makes Tecentriq the first cancer immunotherapy available in Europe for the initial treatment of extensive-stage small cell lung cancer, marking an important step forward for patients,” Sandra Horning, MD, said in another press release. Horning is chief medical officer and head of global product development at Roche. “The combination of Tecentriq and chemotherapy has been shown to improve survival compared to the current standard-of-care — an advance that, until now, has been difficult to achieve due to the refractory nature of this disease.”

The approvals were all based on findings from the randomized, double-blind, placebo-controlled IMpower133 Phase 3 trial (NCT02763579), which compared the safety and effectiveness of Tecentriq in combination with chemotherapy, to that of a placebo plus chemotherapy, in a group of 403 patients with ES-SCLC who never had been exposed to chemotherapy.

The trial’s primary outcomes included assessing patients’ overall survival (OS) and the time until disease progression or death, whichever occurred first (progression-free survival, or PFS).

Key findings from IMpower133 showed that:

• Adding Tecentriq to chemotherapy agents prolonged patients’ OS from 10.3 to 12.3 months, which corresponded to a reduction of 30% in the risk of death;
• Tecentriq prolonged patients’ PFS from 4.3 to 5.2 months, corresponding to a 27% reduction in the risk of disease progression or death;
• The safety profile of the combo therapy was consistent with what had  been reported previously for Tecentriq when used alone;
• The incidence of severe (grade 3) and life-threatening (grade 4) treatment-related adverse side effects was similar in both treatment groups (56.6% in the Tecentriq group and 56.1% in the chemotherapy group);
• The most common severe or life-threatening adverse side effects reported in patients receiving the combo therapy were low levels of blood cells, including neutrophils, red blood cells, and platelets;
• Six deaths were reported in the study, three in each treatment group.

Twelve Phase 3 clinical trials assessing the safety and effectiveness of Tecentriq, either alone or in combination with other medications, are underway in patients with different types of lung cancer. Roche  also is exploring the therapeutic potential of Tecentriq in other types of cancers, including genitourinary, skin, breast, gastrointestinal, gynecological and head and neck cancers.