The U.S. Food and Drug Administration (FDA) has approved Tecentriq (atezolizumab) in combination with chemotherapy — Abraxane (nab-paclitaxel) plus carboplatin — as a first-line treatment for patients with metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors do not have any mutations in the EGFR or ALK genes.
Tecentriq is an immune checkpoint inhibitor (an immunotherapy that blocks the proteins that stop the immune system from attacking cancer cells). It is developed and marketed by Genentech, a Roche subsidiary, and has been approved by the FDA and the European Commission (EC) to treat certain types of cancer, including bladder and lung cancer.
The decision to approve this Tecentriq combo was based on data from the open-label, randomized, IMpower130 Phase 3 clinical trial (NCT02367781), in which the combination extended the lives of metastatic non-squamous NSCLC patients by a median of 4.7 months compared to chemotherapy alone, while also increasing the time without disease progression.
IMpower130 included a group of 724 untreated patients were assigned randomly at a ratio of 2:1 to receive either 21-day cycles of Tecentriq in combination with chemotherapy (Abraxane plus carboplatin), or chemo alone.
Treatment continued for four or six cycles, or until loss of clinical benefit, whichever occurred first. People in the Tecentriq group received Tecentriq in the maintenance phase until loss of clinical benefit; those in the chemo arm were offered best supportive care.
The trial’s primary outcomes included overall survival and the time until disease progression or death, whichever occurred first (progression-free survival).
Findings revealed that adding Tecentriq to chemotherapy agents prolonged patients’ lives from a median of 13.9 to 18.6 months. The combo treatment also prolonged the time patients lived without showing signs of disease progression from 6.5 to 7.2 months.
The safety profile of the Tecentriq-chemo combo was consistent with the known safety profiles of individual medications. No new safety concerns were identified for this specific combination.
Severe (grade 3) and life-threatening (grade 4) treatment-related adverse events were more frequent among those treated with Tecentriq (73.2%) than among those treated with chemo alone (60.3%).
“We are pleased to offer this Tecentriq-based combination as a new treatment option that can provide a clinically meaningful survival benefit for people with non-squamous non-small cell lung cancer,” Levi Garraway, MD, PhD, head of Global Product Development and chief medical officer at Roche, said in a press release.
“Today’s approval offers another opportunity to help prolong the lives of people with this type of the disease,” Garraway said.
The FDA previously approved Tecentriq in combination with Avastin (bevacizumab), Taxol (paclitaxel) and carboplatin for the same indication in December 2018. Tecentriq also is approved in the U.S. as a first-line treatment for adults with extensive-stage small cell lung cancer (ES-SCLC), when used in combination with carboplatin and etoposide.
Nine 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.