Biotech Stocks Rally After Roche's (RHHBY) Accidental Data Leak
On Aug 23, shares of several biotech companies rose after pharma-giant Roche‘s RHHBY stated that it was made aware of inadvertent disclosure of an interim analysis of data from a late-stage study for initial treatment of patients with PD-L1-high locally advanced or metastatic non-small cell lung cancer (“NSCLC”).
The results were based on an interim data analysis from the ongoing phase III SKYSCRAPER-01 study. The study is evaluating the combination of Roche’s investigational anti-TIGIT drug tiragolumab plus blockbuster PD-L1 drug Tecentriq (atezolizumab), compared to Tecentriq monotherapy, for the indication mentioned above.
Though the company did state that the interim results on the co-primary endpoint of overall survival (“OS”) are yet to mature, management reported a hazard ratio (“HR”) of 0.81 from the study results. Roche intends to continue this study until the final analysis of data.
Per the National Library of Medicines website, HR is equivalent to the odds that an individual in the group with the higher hazard reaches the endpoint first. Thus, a higher ratio likely suggests that the tiragolumab-Tecentriq combination was more effective than treatment with Tecentriq alone. Following the leak, shares of Roche surged 4.3% on Wednesday.
Following the above leak, Roche officially declared the results on its website.
However, the above leak did not benefit Roche alone. In response, shares of other smaller companies developing anti-TIGIT immunotherapies, like Arcus Biosciences RCUS and iTeos Therapeutics ITOS, rose 22.4% and 14.9%, respectively. Like Roche, these companies are also evaluating their TIGIT candidates with an anti-PD-1/L1 therapy for NSCLC indication.
Arcus Biosciences’ anti-TIGIT antibody is domvanalimab, which is also being evaluated in combination with the company’s investigational anti-PD-1 therapy zimberelimab in the phase III ARC-10 study for the first-line treatment of patients with PD-L1-high locally advanced or metastatic NSCLC. Arcus Biosciences is co-developing both drugs in collaboration with Gilead Sciences.
iTeos Therapeutics’ lead pipeline candidate is belrestotug, an anti-TIGIT monoclonal antibody, which is being evaluated in multiple combination studies with GSK’s GSK anti-PD-1 drug Jemperli (dostarlimab) across multiple immuno-oncology indications Similar to the SKYSCRAPER-01 study, iTeos Therapeutics is currently making preparations for its late-stage study to evaluate the belrestotug-Jemperli combination for first-line treatment of patients with PD-1 high NSCLC. iTeos is co-developing belrestotug with GSK.
TIGIT is a novel inhibitory immune checkpoint that suppresses the immune system’s response to cancer. Though the TIGIT pathway is distinct, it complements the PD-L1/PD-1 pathway. It is believed that a dual blockade using an anti-TIGIT therapy and a PD-1/L1 therapy can help overcome immune suppression and restore the immune response.
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