Roche’s Tecentriq Approved by FDA for PD-L1 High NSC Lung Cancer

Roche (SIX: RO, ROG; OTCQX: RHHBY) has announced the approval of Tecentriq (atezolizumab) as a first-line therapy for adults with PD-L1-high metastatic non-small cell lung cancer (NSCLC) by the United States Food and Drug Administration (FDA).

The move follows interim results from the phase 3 IMpower110 clinical trial, which found that treatment of this patient population with Tecentriq was associated with a statistically significant improvement in overall survival as compared to chemotherapy.

Tecentriq will now be available as an initial treatment option for individuals with tumors or tumor-infiltrating immune cells that are found to bear high levels of the cell surface protein programmed death-ligand 1 (PD-L1) based on a test approved by the FDA. The patients must have NSCLC that does not have aberrations in the EGFR or ALK genes.

Chief Medical Officer and Head of Global Product Development Levi Garraway, MD, PhD, stated, “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.”

“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,” Dr. Garraway continued.

The randomized, open-label, phase 3 IMpower110 clinical trial evaluated the efficacy and safety of Tecentriq for the treatment of stage IV non-squamous or squamous NSCLC in comparison to that of the chemotherapy agent combinations cisplatin or carboplatin and pemetrexed or gemcitabine. Participants were selected for the trial based on PD-L1 expression and chemotherapy treatment history.

Of 572 enrolled patients, 554 were in the “intention-to-treat WT population which excluded people with EGFR or ALK genomic tumour aberrations,” and were randomly assigned to treatment with Tecentriq monotherapy or with Cisplatin or carboplatin, at the discretion of the study investigator.

Patients receiving chemotherapy were also treated with “pemetrexed (non-squamous) or gemcitabine (squamous) followed by maintenance therapy with pemetrexed alone (non-squamous) or best supportive care (squamous).”

Treatments were continued until “disease progression, loss of clinical benefit, unacceptable toxicity, or death.”

Overall survival was the primary endpoint. Secondary endpoints included progression-free survival, duration of response, and objective response rate. The trial did not identify any “new safety signal” associated with the use of the drug.

By binding to PD-L1 and inhibiting its interaction with the receptor proteins PD-1 and B7.1, the monoclonal antibody Tecentriq (atezolizumab) promotes the anti-cancer activity of T cells, permitting their proliferation and weaponization within tumors.

Tecentriq is approved by the FDA for four non-small cell lung cancer indications in the United States, including as a single agent or in combination with other medications, and is approved as a first-line treatment for extensive-stage small lung cancer in adults in combination with the chemotherapy agents carboplatin and etoposide.

NSCLC is the most common variety of lung cancer, the tumor type that accounts for the highest number of cancer-associated mortalities globally. Squamous-cell carcinoma accounts for 25-30% of NSCLC cases and primarily results from cigarette smoking.

Roche is evaluating or intends to evaluate the utility of Tecentriq alone or in combination with other therapies for treating a variety of cancers including those of the lungs, breast, skin, and gastrointestinal tract, among other locations.

The results of a phase 3 clinical trial evaluating the efficacy of a metastatic non-small cell lung cancer treatment approach combining the monoclonal antibodies Opdivo and Yervoy was recently announced by Bristol Myers Squibb.