TL;DR
TIGIT-targeting drugs, once hailed as the next big breakthrough after Keytruda, faced recent clinical failures. Roche’s tiragolumab showed early promise but did not meet expectations in phase 3 trials. The setback questions the future of TIGIT as a cancer treatment target.
Roche’s experimental TIGIT immunotherapy drug, tiragolumab, failed to meet primary endpoints in a recent phase 3 clinical trial, marking a significant setback for the once-promising cancer treatment class. This failure impacts multiple companies that invested heavily in TIGIT drugs, raising questions about the future of this approach in oncology.
In May 2022, Roche announced that its phase 3 trial of tiragolumab, combined with standard chemotherapy for non-small-cell lung cancer (NSCLC), did not achieve statistically significant improvement in patient survival compared to the control group. This trial was part of a broader effort called ‘SKYSCRAPER,’ involving over 5,000 patients across multiple indications, with billions invested.
Prior to this, tiragolumab showed promising results in early trials, including a phase 2 study presented at ASCO 2020, which demonstrated response rates of 31% versus 16% for placebo. The FDA granted it breakthrough status in January 2021, and Roche rapidly moved into phase 3 testing. Several other pharmaceutical companies, including Merck, BMS, BeiGene, Arcus, and GSK, also developed their own anti-TIGIT drugs, investing heavily in parallel trials.
Why It Matters
The failure of tiragolumab in phase 3 trials signifies a major blow to the optimism surrounding TIGIT as a viable target for cancer immunotherapy. It dampens expectations for other drugs in this class and could influence ongoing and future research investments. The setback also underscores the difficulty of translating promising early results into clinical success in oncology, especially for immune checkpoint targets.
Immune Checkpoint Inhibitors in Cancer
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Background
Over the past decade, immune checkpoint inhibitors like Keytruda revolutionized cancer treatment by blocking proteins such as PD-1. TIGIT, a receptor believed to act as an immune ‘brake,’ emerged as a promising target based on preclinical and early clinical data. Roche’s initial success with tiragolumab in early trials fueled industry-wide enthusiasm, leading to multiple companies developing similar drugs and investing billions in large-scale trials. However, despite the initial hype, recent phase 3 trial results have dashed expectations, echoing past disappointments seen with other drug classes like amyloid-beta treatments for Alzheimer’s.
“The phase 3 trial did not meet its primary endpoints, and we are carefully analyzing the data to determine next steps.”
— Roche spokesperson
“The TIGIT story was highly promising, but this setback highlights how challenging immune checkpoint targets remain in oncology.”
— Industry analyst
TIGIT immunotherapy drugs
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What Remains Unclear
It remains unclear whether other TIGIT drugs in development will face similar outcomes or if modifications to trial design or patient selection could salvage the approach. The full data from Roche’s trial has not yet been publicly released, and the reasons for failure are still under analysis.
Cancer Chemotherapy, Immunotherapy, and Biotherapy
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What’s Next
Pharmaceutical companies involved in TIGIT research are likely to reassess their strategies, potentially shifting focus away from this target. Further detailed analysis of trial data is expected over the coming months, and researchers may explore alternative approaches or combination therapies to revive interest in TIGIT-based treatments.
Oncology Clinical Trials: Successful Design, Conduct, and Analysis, Second Edition – Oncology Clinical Trials Book for Designing, Conducting and Analyzing Clinical Trials, Book and Free eBook
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Key Questions
What is TIGIT and why was it considered promising?
TIGIT is a protein on immune cells believed to act as a brake on immune responses. Blocking it was thought to unleash the immune system against tumors, similar to other successful checkpoint inhibitors like Keytruda.
Why did the tiragolumab trial fail?
The specific reasons are still under investigation, but the trial did not meet its primary endpoints for improving patient survival, suggesting the target may not be as effective as hoped.
What does this mean for future cancer immunotherapies?
The failure casts doubt on TIGIT as a viable target, likely shifting research focus toward other immune pathways or combination strategies.
Are other TIGIT drugs still in development?
Yes, multiple companies are still pursuing TIGIT inhibitors, but the recent setback may slow or halt progress for some of these candidates.
Source: Hacker News
