Policy & Regulation
FDA Grants Priority Review to Genentech's Tecentriq Monotherapy as First-line Treatment of Certain People with Advanced Non-small Cell Lung Cancer
20 February 2020 - - The US Food and Drug Administration has accepted US-based biotechnology company Genentech's supplemental Biologics License Application and granted Priority Review for Tecentriq (atezolizumab) as a first-line (initial) monotherapy for people with advanced non-squamous and squamous non-small cell lung cancer (NSCLC) without EGFR or ALK mutations with high PD-L1 expression (TC3/IC3 wild-type [WT]), as determined by PD-L1 biomarker testing, the company said.

Genentech is a member of Switzerland's Roche Group (SIX: RO) (OTCQX: RHHBY).

The FDA is expected to make a decision on approval by June 19, 2020.

This sBLA is based on results from the Phase III IMpower110 study, which showed that Tecentriq monotherapy improved overall survival by 7.1 months compared with chemotherapy (median OS=20.2 versus 13.1 months; hazard ratio [HR]=0.595, 95% CI: 0.398–0.890; p=0.0106) in people with high PD-L1 expression (TC3/IC3-WT).

Safety for Tecentriq appeared to be consistent with its known safety profile, and no new safety signals were identified.

Grade 3-4 treatment-related adverse events were reported in 12.9% of people receiving Tecentriq compared with 44.1% of people receiving chemotherapy.

Genentech has an extensive development program for Tecentriq, including multiple ongoing and planned Phase III studies across lung, genitourinary, skin, breast, gastrointestinal, gynecological and head and neck cancers.

This includes studies evaluating Tecentriq both alone and in combination with other medicines.

IMpower110 is a Phase III, randomized, open-label study to evaluate the efficacy and safety of Tecentriq monotherapy compared with cisplatin or carboplatin and pemetrexed or gemcitabine (chemotherapy) in PD-L1-selected, chemotherapy-naïve participants with advanced non-squamous or squamous NSCLC without ALK or EGFR mutations.

A total of 572 people (555 WT) were enrolled and were randomized 1: 1 to receive:

Tecentriq monotherapy, until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity or death; or

Cisplatin or carboplatin (per investigator discretion) combined with either pemetrexed (non-squamous) or gemcitabine (squamous), followed by maintenance therapy with pemetrexed alone (non-squamous) or best supportive care (squamous) until disease progression, unacceptable toxicity or death.

The primary efficacy endpoint is OS by PD-L1 subgroup (TC3/IC3-WT; TC2/3/ IC2/3-WT; and TC1,2,3/IC1,2,3-WT), as determined by the SP142 assay test. Key secondary endpoints include investigator-assessed progression-free survival, objective response rate and duration of response.

According to the American Cancer Society, it is estimated that more than 228,000 Americans will be diagnosed with lung cancer in 2020, and NSCLC accounts for 80-85% of all lung cancers.

It is estimated that approximately 85% of lung cancer diagnoses in the United States are made when the disease is in the advanced stages.

Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1. Tecentriq is designed to bind to PD-L1 expressed on tumor cells and tumor-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors.

By inhibiting PD-L1, Tecentriq may enable the re-activation of T cells. Tecentriq may also affect normal cells.
Login
Username:

Password:


Related Headlines