The U.S. Food and Drug Administration will review Genentech‘s Tecentriq (atezolizumab), in combination with chemotherapy medications Abraxane (nab-paclitaxel) and carboplatin, as a first-line treatment for metastatic non-squamous non-small cell lung cancer (NSCLC), the company announced.
The supplemental biologics license application is for patients without any mutations in the EGFR and ALK genes, and a final decision on approval is expected by Sept. 2.
“We look forward to working with the FDA in order to bring this Tecentriq-based combination to people with non-squamous non-small cell lung cancer as soon as possible,” Sandra Horning, MD, Genentech’s chief medical officer and head of global product development, said in a press release.
“Lung cancer is a challenging disease to treat, and this review takes us one step closer towards offering a new treatment option that has shown a clinically meaningful survival benefit in the treatment of this type of disease,” she added.
Genentech’s application is based on data from a Phase 3 clinical trial (NCT02367781), called IMpower130, where a combination of Tecentriq and chemotherapy — Abraxane and carboplatin — extended survival and delayed disease worsening compared with chemotherapy only.
The trial included 724 NSCLC patients who had not received any prior treatment for their metastatic disease. Patients were randomly assigned the Tecentriq combination (483 patients) or chemotherapy only (241 patients). After completing chemotherapy — which was given for up to six cycles — patients continued receiving Tecentriq until their disease progressed, or were given best supportive care.
Patients in the control group were also allowed to receive maintenance treatment with Alimta (pemetrexed), and some patients were also given the option to cross over to Tecentriq until further disease progression.
The trial’s main objectives were to determine if Tecentriq improved overall survival and kept patients alive and without disease progression for longer than chemotherapy. Secondary measures included the proportion of patients responding to treatment, duration of responses, and adverse events.
IMpower130 reached both its primary goals, extending patients’ lives from 13.9 months to 18.6 months, and reducing the risk of disease progression or death by 36%.
Safety data for the combo therapy matched that of its individual components. A total of 73.2% of patients receiving the Tecentriq combination experienced a serious or life-threatening adverse event, compared with 60.3% of those receiving chemotherapy only.
Tecentriq is a so-called checkpoint inhibitor, which targets the PD-L1 protein. Cancer cells use binding of their own PD-L1 to the PD-1 receptor on immune cells to avoid attack. Checkpoint inhibitors block this binding, boosting immune response against tumor cells.
Tecentriq, in combination with Avastin (bevacizumab) and the chemotherapies Taxol (paclitaxel) and carboplatin, was approved in December 2018 as a first-line treatment for non-squamous NSCLC patients without EGFR or ALK mutations in their tumors.