A year into Roche’s comprehensive portfolio review, the Swiss pharma said it has now taken out 25% of new drug candidates from its pipeline. The ongoing exercise will create room for it to keep bringing in innovation from outside such as the weight loss drugs from Carmot Therapeutics, CEO Thomas Schinecker said.
Among the programs dropped in the second quarter are two trials involving its TIGIT drug tiragolumab, in light of a recent Phase 3 failure. The cuts, alongside new programs being added to the pipeline, are part of a refined R&D strategy that Schinecker’s top team has been rolling out.
While Roche has yet to unveil its finalized pharma strategy — it plans to do so at its Pharma Day in September — execs said they have begun communicating it within the organization and implementing it in day-to-day decision making.
That includes the introduction of “the bar,” which Schinecker described as five criteria that potential medicine needs to meet in order to stay in the portfolio, and “fast track” status for key, high-priority programs.
“This prioritization process has happened, basically, since Q2 last year, where we reviewed the entire portfolio,” he said at a media conference. “I would say this is now routine, and it’s something that we need to continuously do.”
Despite shifting “a lot of money” around, Schinecker offered a “very clear statement” that “there will be no announcement of any big restructuring.”
“We don’t believe in making huge cuts in our organization, because we want our team to be focused and diligent on developing medicines, and any such distraction would not be something that we would want in the organization,” he said.
Fast-tracking obesity development
Obesity has come into the spotlight at Roche following back-to-back readouts on candidates from Carmot, which it acquired last year for $2.7 billion. They include an oral GLP-1 and a once-weekly injectable GLP-1/GIP agonist.
Like other companies who are chasing Novo Nordisk and Eli Lilly in the space, Roche noted the potential for combinations with its existing portfolio — including a compound designed to counter muscle atrophy and others that could address various kidney conditions.
When asked when Roche may have a commercial product on its hands, Schinecker said the hope is to “get on the market a bit earlier” than current predictions, but refrained from further details.
“When it comes to timelines, we have very different timelines in mind than some people on the outside,” he said. “So this is one of the programs we’re accelerating significantly.”
TIGIT trial closures
In July, Roche reported that tiragolumab had flunked the SKYSCRAPER-06 trial, testing the TIGIT drug in combination with Tecentriq and chemotherapy in first-line non-small cell lung cancer. The disappointing results pushed Roche to reevaluate the program, and it decided to close two more studies, according to Roche Pharma CEO Teresa Graham.
Teresa GrahamOf the two trials, SKY-15 was a Phase 3 targeting adjuvant NSCLC in Phase 3, while SKY-05 was a Phase 2 focused on neoadjuvant NSCLC. The company stopped short of commenting on any other next steps.
“The remaining tiragolumab studies have either already completed, are already fully enrolled or are almost fully enrolled,” Graham said. “So those studies are obviously kind of already quite down the path. We’re going to allow those to close out.”
Other trials on chopping block
Roche has swept three other early-stage candidates from its pipeline and trimmed an additional indication for an orphan drug, a spokesperson confirmed to Endpoints News.
One of Spark’s gene therapy candidates, the Phase 2 RG6359 (SPK-3006) for Pompe disease, is being cut. Its removal follows recent layoffs and pipeline restructuring at Spark.
The company is also dropping two cancer programs: RG6292, or vopikitug, a CD25 antibody that was tested in solid tumors; and RG6333, a CD19xCD28 bispecific tested in combination with Columvi in non-Hodgkin lymphoma.
Finally, Roche said it won’t continue to develop crovalimab in lupus nephritis. The drug recently won FDA approval in paroxysmal nocturnal hemoglobinuria.