FDA Approves Tecentriq as Initial Treatment for Advanced NSCLC

FDA Approves Tecentriq as Initial Treatment for Advanced NSCLC

The U.S. Food and Drug Administration (FDA) has approved Genentech‘s Tecentriq (atezolizumab) as an initial treatment of people with metastatic non-small cell lung cancer (NSCLC) whose tumors produce high levels of the PD-L1 protein but have no alterations in the EGFR or ALK genes.

Approval was based on findings from the IMpower110 Phase 3 trial (NCT02409342), which showed that Tecentriq significantly extended patients’ survival compared with chemotherapy, without impacting quality of life.

This is the second immunotherapy regimen approved by the FDA for the first-line treatment of advanced NSCLC patients in one week, after a combination of Opdivo (nivolumab) and low-dose Yervoy (ipilimumab) received the regulatory agency’s nod for people whose tumors produce PD-L1.

It is also the fifth U.S. approval of Tecentriq for people with lung cancer — four are for metastatic NSCLC patients and one for those with small cell lung cancer. In such cases, Tecentriq may be used as a single agent or in combination with targeted therapies and/or chemotherapies.

According to Genentech (owned by Roche), Tecentriq is the only stand-alone cancer immunotherapy that can be given every two, three, or four weeks.

“Today marks the fifth approval of Tecentriq in lung cancer, as we remain committed to providing an effective and tailored treatment option for every person diagnosed with this disease,” Levi Garraway, MD, PhD, chief medical officer and head of Global Product Development at Genentech, said in a press release.

“We are pleased to offer people with certain types of lung cancer a new chemotherapy-free option that can help prolong their lives and be administered on a flexible dosing schedule, including an option for once-a-month Tecentriq infusions,” Garraway added.

Tecentriq belongs to the family of immune checkpoint inhibitors, a class of immunotherapies that work by blocking signals that enable cancer cells to evade immune responses. In particular, Tecentriq targets the PD-L1 protein on cancer cells, and prevents it from binding PD-1 on T-cells — immune cells that can fight cancers — enabling greater anti-tumor response.

The Phase 3 IMpower110 trial is investigating the safety and efficacy Tecentriq, when given as initial treatment to metastatic NSCLC patients. The Roche-sponsored study includes 572 patients, 554 of whom lacked the common ALK and EGFR mutations seen in lung cancer patients.

Participants were randomly assigned to receive either Tecentriq or chemotherapy every three weeks for up to 58 months (nearly five years), or until disease worsening or signs of toxicity were evident. Those on the chemotherapy group received cisplatin or carboplatin along with either gemcitabine — for those with squamous cancer — or Alimta (pemetrexed) for patients with non-squamous NSCLC.

The study’s primary goal was to determine whether Tecentriq increased overall survival compared with chemo in patients whose tumors had high levels of PD-L1 — defined as at least 50% of tumor cells being positive for this protein, or at least 10% of the tumor area covered with PD-L1 positive immune cells, as determined by an FDA-approved test.

Survival outcomes were also assessed in patients with medium and low levels of this protein. Secondary measures included the time patients lived without disease worsening, proportion of patients responding to treatment, and duration of response.

An interim analysis showed the trial met its primary goal, with Tecentriq monotherapy extending survival to 20.2 months, from 13.1 months among those given chemotherapy, in patients with high PD-L1 expression. This 7.1 month extension in survival represented a 41% reduction in the risk of death.

Survival in people with lower levels of PD-L1, however, was not significantly improved by Tecentriq compared with the chemo regimens.

The researchers also examined the effects of Tecentriq on several patient-reported outcomes, including quality of life, time to worsening in lung cancer symptoms, and changes in global health status.

Results demonstrated that Tecentriq did not worsen symptoms like cough, chest pain, or shortness of breath compared with chemo, modestly improved physical functioning, and eased nausea and vomiting.

These findings will be presented at the upcoming  American Society of Clinical Oncology Annual Meeting, which will be held online, in the poster “Patient-reported outcomes (PROs) in the randomized, phase III IMpower110 study of atezolizumab (atezo) vs chemotherapy in 1L metastatic NSCLC.”

Tecentriq’s safety profile was consistent with previous studies, and no new safety signals were observed. Serious or life-threatening treatment-related adverse events were more common in the chemo arm (44.1%) than with this immunotherapy (12.9%).