An unexpected revelation has provided the world with a sneak peek into Roche’s highly anticipated TIGIT data. Roche, which had kept its research findings closely guarded during the phase 3 lung cancer study, inadvertently published interim results for overall survival after they were unintentionally exposed.
The disclosed data originates from Roche’s SKYSCRAPER-01, a phase 3 clinical trial evaluating the combination of the anti-TIGIT antibody tiragolumab with the checkpoint inhibitor Tecentriq in first-line non-small cell lung cancer (NSCLC) patients. Last year, Roche had disclosed that adding tiragolumab to Tecentriq did not lead to an improvement in progression-free survival (PFS), causing the study to miss one of its co-primary endpoints. However, exact figures were not shared at that time.
Earlier this year, Roche had mentioned that the clinical trial was ongoing beyond an interim analysis of its overall survival (OS) endpoint. The latest update confirms that the interim OS data did not warrant halting the trial, implying neither exceptionally positive nor negative outcomes. Yet, it did not provide insight into the trial’s prospects for success in its final analysis.
In a surprising turn, Roche has now divulged the results of a second interim analysis conducted in February. By the cutoff date in November 2022, the estimated median overall survival for patients receiving the tiragolumab combination was 22.9 months, in contrast to 16.7 months for those on Tecentriq monotherapy. The hazard ratio stood at 0.81, with a median follow-up duration of 15.5 months during the analysis.
Although the interim analysis indicates a longer lifespan for individuals on tiragolumab, the increase wasn’t substantial enough to attain statistical significance as of the November cutoff. The ultimate reckoning lies in the final analysis, scheduled for the third quarter, which will determine whether Roche can rebound from the PFS setback and advance tiragolumab to the NSCLC market.
The accidental leak of Roche’s OS data has bolstered investor confidence, driving Roche’s shares up by 4.5% to 264 Swiss francs ($300) during early trading in Switzerland following the data’s disclosure.
This unexpected data drop has also spurred a positive ripple effect on other TIGIT-related stocks. Pre-market trading witnessed Arcus Biosciences and iTeos Therapeutics shares surging over 20%, reigniting investor enthusiasm for a target that has so far failed to make a significant impact.
Experts at Evercore have hailed this inadvertent data release as “highly promising.”
“Observing the trends, they are visibly expanding,” noted the Evercore analysts in a morning statement. “This suggests that by the time of the final analysis, the hazard ratio could potentially improve to just under 0.8.”
J.P. Morgan analysts highlighted that the latest findings “indicate… the trial might still exhibit statistical significance during the final analysis.” Nonetheless, they remarked that the “detailed data” did not significantly alter their overall perspective on tiragolumab’s potential.
Leerink Partners analysts remarked that it remains “ambiguous whether the relative benefit of tira[golumab] will enhance enough to meet SKY-01’s stringent statistical threshold.”
This unforeseen data revelation has injected renewed vigor into the TIGIT landscape, raising both hopes and questions about the potential impact of tiragolumab’s efficacy in combating NSCLC.
