Roche’s long-running bet on a new kind of cancer immunotherapy has, after years of shrinking optimism and second-guessing by analysts on Wall Street, come up empty — at least for now.
On Tuesday, Roche said that much-anticipated results from a Phase 3 trial called SKYSCRAPER-01 showed the drug, tiragolumab, did not help people with advanced or metastatic lung cancer live longer. The company didn’t disclose any specific data in its statement, but confirmed the trial did not meet its primary goal.
Full findings will be presented at a medical meeting next year, said Roche, which plans to review its plans for tiragolumab development to “determine if any adjustments are necessary for the purposes of ongoing research.” The company has a handful of other studies testing the drug in cancers of the liver, esophagus, head and neck. Data from some of those trials are expected next year.
Tiragolumab is aimed at an immune cell protein called TIGIT, a drug target that was uncovered by scientists at Roche’s Genentech subsidiary. Researchers there have been studying TIGIT’s role in suppressing the immune system’s response to cancer for more than a decade. Tiragolumab, which binds to TIGIT to block those signals, was the result of their efforts and, after promising mid-stage trial results, became one of Roche’s top pipeline assets.
But since Roche embarked on a major Phase 3 study program, it has hit repeated setbacks proving that blocking TIGIT can add substantial benefit over existing immunotherapies like its approved drug Tecentriq. A trial testing tiragolumab in small cell lung cancer failed in 2022 and then, a few months later, data from SKYSCRAPER-01 showed treatment failed to slow tumor progression.
Roche kept the faith, continuing on with SKYSCRAPER-01 to see whether treatment could improve survival, the study’s other main goal. The company’s perseverance initially seemed warranted when inadvertently published data from an interim analysis indicated patients treated with tiragolumab were living longer.
Tuesday’s disclosure comes from the study’s final analysis, however, suggesting the benefit seen earlier either was not sustained in further follow-up, or wasn’t significant enough to declare success.
The trial, which enrolled 534 people with previously untreated non-small cell lung cancer, tested tiragolumab together with Tecentriq against Tecentriq alone. Participants’ tumors had to have high levels of PD-L1, which has been correlated with greater response rates to immunotherapies like Tecentriq.
Roche’s roller coaster with TIGIT was shared by other cancer drugmakers, which piled into TIGIT drug development in hopes of finding treatments as powerfully effective as the PD-1 and PD-L1 inhibitors that made Merck & Co. and Bristol Myers Squibb oncology powerhouses. Merck, Bristol Myers and Gilead Sciences have all invested heavily in TIGIT, as have smaller biotechnology companies like Arcus Biosciences and iTeos Therapeutics.
Some of their studies have since read out negative, leading some companies to back out of development. But others are pressing on and there have been some encouraging data, most recently from iTeos.
“The door finally closes on SKY-01, but TIGIT lives on,” Daina Graybosch, an analyst at Leerink Partners, wrote as the title of a client note Tuesday. In her view, AstraZeneca, which is working with biotech Compugen on a TIGIT drug, Gilead and iTeos could learn from Roche’s setbacks.
“Given recent history, investors are unlikely to give the biotech stocks much credit for these TIGIT programs,” Graybosch wrote. “We hope the SKY-01 failure, and potentially some positive signals from the detailed data next year, can be a turning point for these companies.”
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- Source: https://www.biopharmadive.com/news/roche-tigit-skyscraper-01-survival-negative-failure/733999/