Yahoo Finance Roche (RHHBY) Phase III NSCLC Study Disappoints, Stock Down
Shares of Roche RHHBY were down 9.1% after it announced disappointing results from the phase III SKYSCRAPER-01 study in PD-L1-high metastatic non-small cell lung cancer (NSCLC).
The study evaluated the investigational anti-TIGIT immunotherapy tiragolumab plus Tecentriq (atezolizumab) versus Tecentriq alone as an initial (first-line) treatment in 534 patients with first-line PD-L1-high locally advanced, unresectable or metastatic NSCLC. Patients were randomized 1:1 to receive either tiragolumab plus Tecentriq or placebo plus Tecentriq, until disease progression, loss of clinical benefit or unacceptable toxicity. The co-primary endpoints are overall survival and progression-free survival.
Tiragolumab is an investigational novel immune checkpoint inhibitor with an intact Fc region. Tiragolumab selectively binds to TIGIT, a novel inhibitory immune checkpoint that suppresses the immune response to cancer. Tecentriq is a monoclonal antibody designed to bind with a protein called programmed death ligand-1 (PD-L1), which is expressed on tumor cells and tumor-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors.
However, results showed that the study failed to meet its co-primary endpoint of progression-free survival.
The other co-primary endpoint of overall survival was immature, and the study will continue until the next planned analysis.
Nevertheless, the tiragolumab development program continues as planned in NSCLC and other cancer types.
The TIGIT pathway is distinct but complementary to the PD-L1/PD-1 pathway. Roche hopes that dual blockade with tiragolumab and Tecentriq may help overcome immune suppression and restore the immune response.
Investors were clearly disappointed as anti-TIGIT therapies are a new class of drugs, and they had pinned hopes on the combination.
Roche’s stock has lost 21.5% in the year so far against the industry’s growth of 0.7%.
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In response, shares of other companies like Arcus Biosciences, Inc. RCUS, iTeos Therapeutics, Inc. ITOS, among others, also crashed as these too have anti-TIGIT candidates in their pipeline.
We note that Arcus is co-developing three investigational molecules: domvanalimab, an Fc-silent anti-TIGIT antibody, etrumadenant, a dual adenosine A2a/A2b receptor antagonist, and zimberelimab, an anti-PD1 antibody in partnership with Gilead Sciences GILD.
Domvanalimab (previously referred to as AB154), its Fc-silent anti-TIGIT monoclonal antibody, is being evaluated in combination with zimberelimab with or without etrumadenant vs. zimberelimab monotherapy in ARC-7, a randomized, 150-patient phase II study in first-line metastatic PD-L1≥50% NSCLC. Gilead obtained an exclusive license to domvanalimab in December 2021. GILD and Arcus are co-developing and equally share co-development costs for these molecules.
iTeos Therapeutics antibody product candidate, EOS-448, is a high affinity, potent, anti-TIGIT antibody with a functional Fc domain, designed to enhance the anti-tumor response through a multifaceted immune modulatory mechanism. ITOS is evaluating the candidate in multiple indications in collaboration with Glaxo.
Roche currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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