Roche inadvertently publishes positive interim trial data on lung cancer drug

[August 23, 2023]  By Ludwig Burger and Rachel More

BERLIN (Reuters) -Roche inadvertently published positive lung cancer drug trial data from an interim analysis, boosting the Swiss drug maker's shares even though more data will be needed to confirm the treatment's efficacy.

Roche said on Wednesday that market participants had made it aware of the inadvertent disclosure of an interim data analysis on new immunotherapy tiragolumab, part of an experimental class of drugs known as anti-TIGIT.

In a statement, the company said the data, which was "not mature", showed an overall survival hazard ratio of 0.81, which means that trial participants on the drug had a 19% lower mortality rate than those in a parallel group without the drug.

The read-out is not yet statistically significant, meaning that random effects cannot be ruled out with enough certainty, but a Roche spokesperson said researchers would continue to gather trial data, with more solid survival results due to be published in the first quarter of 2024.

The shares were up 4.5% at 0737 GMT at a one-week high, on track for their best day since late 2020.

Last year, the drug's efficacy was thrown into doubt when study data showed that tiragolumab did not slow disease progression but investors have been holding out for longer-term data on survival to see whether the treatment still has medical and commercial potential.

A logo of Swiss pharmaceutical company Roche in Rotkreuz, Switzerland, April 12, 2012. REUTERS/Michael Buholzer/File Photo

Evercore ISI analysts said in a research note on Wednesday they had "stumbled upon a presentation on Roche website", describing the data as very good.

J.P. Morgan analysts said the interim data suggested a survival benefit was within reach in the final analysis, but the clinical relevance remained uncertain.

The unintended disclosure regards the second interim analysis of a Phase III trial known as Skyscraper 1. It evaluated a combination of tiragolumab and Roche's established Tecentriq drug versus Tecentriq alone, the company added.

Tiragolumab works by selectively binding itself to TIGIT, a receptor on immune system cells that normally serves to prevent a misguided immune attack against healthy cells.

Some cancers have developed a mechanism that exploits TIGIT to continue to grow unnoticed by cell-killing immune cells, prompting intense research into using anti-TIGITs in combination with other cancer drugs.

(Additional reporting by Paul Arnold in ZurichEditing by Jason Neely, Friederike Heine and Mark Potter)

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