Roche has halted five early and midstage trials covering a range of cancer, asthma and metabolic disease drugs. And when it looks to the future, the Swiss pharma admits that two of its most exciting prospects remain high-risk.
The cuts include the Akt kinase inhibitor ipatasertib, also known as RG7440, which the company is removing from a phase 1 trial for prostate cancer, as well as a separate early-stage trial in combination with Rubraca for solid tumors and castration-resistant prostate cancer (CRPC) that has spread.
Ipatasertib has run into trouble before, with Roche scrapping two phase 3 trials in breast cancer of combos that included the drug last year. According to a second-quarter earnings presentation (PDF) released Tuesday morning, the latest trial updates leave the company with one remaining ongoing study for ipatasertib: a phase 3 in combination with Zytiga for CRPC.
Another phase 1 that has been dumped is RG6338 for metabolic disease.
Midstage trials weren’t spared, either, with the anti-tryptase RG6173 designed to target inflammation associated with asthma. The 135-participant study completed in May 2022, according to ClinicalTrials.gov.
Fierce Biotech has contacted Roche for more details about why the trials were scrapped.
The drugmaker also confirmed it had removed a phase 2 trial for giredestrant for second and third line estrogen receptor-positive, human epidermal growth factor receptor 2-negative locally advanced or metastatic breast cancer after missing the mark in April. However, the Big Pharma has by no means given up on the estrogen receptor degrader, with three phase 3 trials ongoing for a range of breast cancers.
Risks for the future
It’s by no means plain sailing for the future, either. Analysts at financial services company ODDO BHF said the clinical catalysts expected for Roche in the second half of the year are “risky.” These include detailed results of the TIGIT-targeted antibody tiragolumab and Alzheimer’s treatment gantenerumab.
On a call with analysts this morning, Roche CEO Severin Schwan agreed that gantenerumab, which is in phase 3, is a “high risk project.”
“We hope for the best, but don’t plan on that basis,” said Schwan, who announced today that he would become chairman of the company, to be replaced as CEO by Thomas Schinecker, Ph.D., the current head of the diagnostics division.
Tiragolumab has also faced a rocky few months. Two phase three flops raised doubts about the very future of TIGIT therapies, and Roche has yet to reveal the full data from the ongoing trial for non-small cell lung cancer.
“Let’s face it, it was a setback,” Schwan said of the second trial failure in May. The results had delayed by at least a year the drugmaker’s attempts to get the first TIGIT to market, the CEO said.
“In the case that overall survival [data] is positive, I think we can still salvage a lot of value of tiragolumab,” he added on the call.
Pushed by an analyst on the call to hint at the tiragolumab data Roche is sitting on, Roche Pharmaceuticals CEO Bill Anderson remained tight lipped but stressed the company hadn’t given up on the drug.
“The fact we’re still talking about it … suggests we’re reasonably optimistic it’s going to be a medicine,” Anderson said.