Roche's anti-TIGIT immunotherapy fails lung cancer study

Roche said yesterday that it was shutting down a Phase 3 study after an analysis showed its immunotherapy directed against a target called TIGIT failed to prolong survival or delay tumor growth in certain patients with lung cancer.

The disappointing study outcome is likely to cast new doubts on Roche's effort to develop the drug, called tiragolumab, into the next cancer immunotherapy blockbuster.

The Phase 3 study called SKYSCRAPER-06 enrolled patients with previously untreated, metastatic non-small cell lung cancer. In a final analysis, the combination of tiragolumab and Tecentriq, Roche's anti-PD-L1 immunotherapy, showed a 27% greater risk of tumor progression compared to Keytruda and chemotherapy, the current standard of care for these patients.

Roche also performed an interim analysis for survival, showing a 33% increased risk of death for the patients treated with the tiragolumab regimen compared to standard therapy. For this reason, the company stopped the study.

A series of Phase 3 studies investigating tiragolumab in different types of cancer remain underway. Survival results from a second Phase 3 study in lung cancer called SKYSCRAPER-01 are expected later this year.

Other anti-TIGIT drugs are being developed by Merck, Gilead Sciences in partnership with Arcus Biosciences, and GSK in partnership with Iteos Therapeutics.

Adverse events

Study suggests possible link between GLP-1 drugs and vision loss

A new study shows a potential link between GLP-1 drugs like Ozempic and Wegovy and a rare but serious form of vision loss. The study was prompted by patients taking the Novo Nordisk drugs sometimes reporting nonarteritic anterior ischemic optic neuropathy, or NAION.

The study looked at data from more than 1,600 patients, including those with type 2 diabetes and obesity. Among the diabetes patients, those taking semaglutide had a significantly higher rate of NAION compared to those taking other diabetes drugs. Similarly, in the obesity group, the rate of NAION was notably higher in patients using semaglutide compared to those on different weight-loss medications.

The authors stress, though, that this observational study does not show that the drugs cause higher rates of NAION — just that there is a potential association.

Therapeutics

ALS patients need a better system for expanded access

After developing ALS, electrical engineer Lynn Brielmaier found hope in the FDA's expanded access program, which allows patients with serious illnesses to access experimental treatments outside of clinical trials. However, bureaucratic hurdles and delays have hindered the timely distribution of these potentially life-extending therapies.

Opining for STAT, Brielmaier emphasizes the need for a more efficient system to grant access to investigational therapies. While legislative and funding steps have been taken to support expanded access programs, implementation has been slow, leaving many patients without much-needed treatments.

"People living with ALS — and those with other fatal diseases — deserve a seamless system that helps them get access to treatments that might extend their lives," Brielmaier writes.

space

What we can learn from the Space Omics report

This summer will mark the first commercial spacewalk, with SpaceX taking four civilian astronauts over 430 miles above Earth. Christopher Mason, a geneticist and computational biologist, is particularly excited about the mission's findings — and helped spearhead the Space Omics and Medical Atlas, which aims to establish a baseline for human health in space.

The atlas has interesting implications for the biotechnology industry: As space travel becomes more accessible, Mason said, it could help develop countermeasures against space-related health issues, such as radiation exposure and changes in gene expression. The atlas also paves the way for personalized medicine in space, enabling tailored treatments for astronauts based on their genetic profiles.