SWITZERLAND—The Swiss drugmaker Roche has terminated a trial for a combination lung cancer treatment after the results fell short of efficacy expectations, putting fresh doubt on the company’s experimental immunotherapy.
This decision follows the disappointing outcomes from its Phase II/III SKYSCRAPER-06 clinical trial.
The trial evaluated tiragolumab in combination with Tecentriq (atezolizumab) and chemotherapy as a first-line treatment for non-squamous non-small cell lung cancer (NSCLC) but failed to meet its primary endpoints.
Despite the high hopes, the combination of tiragolumab plus Tecentriq and chemotherapy showed reduced efficacy in both progression-free survival (PFS) and overall survival (OS) compared to the comparator arm in the intent-to-treat population, which includes both Phase II and Phase III cohorts.
Furthermore, the overall safety profile of the treatment was consistent with previous reports, with no new or unexpected safety concerns emerging.
Based on these findings, Roche has decided to unblind the patients and investigators in the trial and subsequently halt the trial.
Commenting on the results, Levi Garraway, M.D., Ph.D., Chief Medical Officer and Head of Global Product Development, expressed his disappointment.
He acknowledged the hope that this combination might yield improved outcomes for people living with metastatic non-squamous lung cancer.
Despite the setback, Dr. Garraway emphasized the importance of the contributions made by all patients and healthcare professionals involved in the study.
He stated that Roche would leverage the learnings from this trial to enhance their scientific understanding of the anti-TIGIT pathway and explore new avenues in cancer research.
Meanwhile, Roche has also announced that the United States Food and Drug Administration (US FDA) has approved its Vabysmo® (faricimab) 6.0 mg single-dose prefilled syringe (PFS) for the treatment of retinal conditions that can lead to blindness.
These conditions include neovascular or ‘wet’ age-related macular degeneration (nAMD), diabetic macular edema (DME), and macular edema following retinal vein occlusion (RVO).
Collectively, these three conditions impact nearly 80 million people worldwide.
Notably, Vabysmo is the first and only bispecific antibody approved for eye treatment and has shown rapid and robust improvements in vision and retinal drying for nAMD, DME, and RVO.
As of now, Vabysmo is approved in more than 95 countries for nAMD and DME, and in several countries, including the US and Japan, for RVO.
Reviews by other health authorities around the world are ongoing.
Since its initial US approval in 2022, over four million doses of Vabysmo have been distributed globally, reflecting the widespread trust and reliance on this treatment by healthcare professionals worldwide.
For all the latest healthcare industry news from Africa and the World, subscribe to our NEWSLETTER, and YouTube Channel, follow us on Twitter and LinkedIn, and like us on Facebook
