FDA Approves Tecentriq Combo as Initial Treatment for Select Patients with Advanced NSCLC

FDA Approves Tecentriq Combo as Initial Treatment for Select Patients with Advanced NSCLC

The U.S. Food and Drug Administration (FDA) has approved Tecentriq (atezolizumab), in combination with Avastin (bevacizumab) and the chemotherapies Taxol (paclitaxel) and carboplatin, for a first-line treatment of certain patients with metastatic non-squamous non-small cell lung cancer (NSCLC).

The approval — which is for patients without EGFR or ALK mutations in their tumors — is based on positive results from the IMpower150 Phase 3 clinical trial (NCT02366143), where the combination significantly extended patients’ lives compared to Avastin and chemotherapy medications.

“This Tecentriq regimen has demonstrated a significant survival benefit in the initial treatment of metastatic non-squamous non-small cell lung cancer,” Sandra Horning, MD, chief medical officer and head of Global Product Development for Genentech, said in a press release. “Today’s approval supports our combination approach for Tecentriq in lung cancer and our vision to develop medicines that improve outcomes for patients with this complex disease.”

Tecentriq is an immune checkpoint inhibitor that targets the PD-L1 protein and prevents it from binding to the PD-1 receptor on immune cells. Cancer cells use this binding to prevent the immune system from recognizing them as foreign. As such, Tecentriq is capable of restoring immune surveillance.

Tecentriq is already approved in the U.S. for second-line treatment of metastatic NSCLC for patients who fail to respond to platinum-based chemotherapy. It is also approved for bladder cancer.

IMpower150 is a multicenter, open-label and randomized trial evaluating the safety and effectiveness of Tecentriq in combination with Taxol and carboplatin, with or without Avastin, in 1,202 patients with metastatic non-squamous NSCLC not previously treated with chemotherapy. The intention to treat (ITT) population, however, only included patients without EGFR or ALK mutations.

Its main objective is to determine if the Tecentriq combination delays disease progression or death and extends patients’ lives compared to Avastin and chemotherapy. Secondary goals include overall response rate, survival rates at one and two years, time to deterioration, changes in lung cancer symptoms, and adverse events.

Patients received either Tecentriq plus carboplatin and Taxol; Tecentriq and Avastin plus carboplatin and Taxol; or Avastin plus carboplatin and Taxol (control group).

They started on an induction therapy, followed by a maintenance treatment until their disease worsened or a loss of clinical benefit was observed. On maintenance treatment, patients received Tecentriq and/or Avastin every three weeks.

Researchers reported that the combination of Tecentriq, Avastin, and chemotherapy significantly extended the lives of patients in the ITT population, compared Avastin plus chemotherapy only — 19.2 months vs. 14.7 months. This represented a 22% lower risk of death among those receiving Tecentriq.

The combination also reduced the risk of disease worsening or death by 29%, and led to better response rates than the Avastin-chemo combination — 55% versus 42%. Responses were also longer with the Tecentriq combination, lasting a median of 10.8 months, compared to 6.5 months for the Avastin combination.

Safety data for the combo therapy matched that of its individual components. The most common adverse events in the Tecentriq arm were fatigue and lack of energy, hair loss, nausea, diarrhea, constipation, reduced appetite, joint pain, high blood pressure, and pain from nerve damage.

Genentech offers assistance programs for patients taking Tecentriq through Genentech Access Solutions, both in terms of medication access and possible reimbursement support to patients who qualify.