Roche says first-line Tecentriq combination meets main goals in Phase III non-squamous NSCLC study

Roche announced Phase III results Tuesday showing that patients with advanced non-squamous non-small-cell lung cancer (NSCLC) who took the company's PD-L1 inhibitor Tecentriq (atezolizumab) plus chemotherapy as a first-line treatment achieved significantly longer overall survival (OS) and progression-free survival (PFS), compared with chemotherapy alone. "Results of the IMpower130 study add to the growing evidence showing the clinical benefit of Tecentriq-based combinations in the treatment of advanced non-squamous NSCLC," commented Sandra Horning, Roche's chief medical officer and head of global product development, adding "we will share these results with global health authorities." 

In the study, 724 chemotherapy-naïve patients with stage IV non-squamous NSCLC were randomly assigned to treatment with Tecentriq plus carboplatin and Celgene's Abraxane (nab-paclitaxel), or carboplatin and Abraxane alone. The co-primary endpoints were PFS and OS in patients without an EGFR or ALK mutation. 

Roche said the safety of the combination regimen "appeared consistent" with the known safety profiles of the individual drugs, while no new safety signals were detected. The company added that the IMpower130 data will be unveiled at an upcoming oncology congress.

Commenting on the news, Deutsche Bank analyst Tim Race explained that because full study results will not be released until later this year, possibly at the International Association for the Study of Lung Cancer (IASLC) meeting in September or the European Society for Medical Oncology (ESMO) conference in October, it "is still very difficult to interpret how Tecentriq stacks up against competitors." Race anticipates $4.7 billion in sales for Tecentriq by 2022, but also warned that biosimilar versions of Roche's older cancer drugs could hamper the company's growth.

Meanwhile, Berenberg analyst Alistair Campbell, who forecasts peak annual revenue of $4 billion for Tecentriq, questioned the extent to which Roche's therapy would be a competitive threat to Merck & Co.'s anti-PD-1 immunotherapy Keytruda [pembrolizumab]. "Keytruda has shown similar success and now has four pivotal trial wins in this disease, and has established a clear lead," Campbell noted (for related analysis, see ViewPoints: Keytruda locks the door on competition (and they know it). 

Earlier this month, Roche unveiled detailed results from the late-stage IMpower150 trial, testing first-line Tecentriq plus Avastin (bevacizumab) and chemotherapy, which had met its co-primary OS endpoint in patients with advanced non-squamous NSCLC. The FDA has awarded priority review to Roche's filing for the combination as a first-line treatment of patients with metastatic non-squamous NSCLC, with a decision expected by September 5.

Meanwhile, Johnson & Johnson recently terminated a Phase Ib/II study of Darzalex (daratumumab) plus Tecentriq for use in previously treated patients with advanced or metastatic NSCLC in response to a recommendation by a data monitoring committee.

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