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Another IO knockback as Tecentriq combo fails phase III trial

The bulk of CRC patients with MSS currently look set to be excluded from cancer immunotherapy

Roche Basel Switzerland

Roche’s hopes of teaming up checkpoint inhibitor Tecentriq with its targeted cancer drug Cotellic have hit a snag after the first phase III assessment of the duo missed the mark.

The IMblaze370 trial of PD-L1 inhibitor Tecentriq (atezolizumab) and MEK inhibitor Cotellic (cobimetinib)  as a third-line treatment option in people with difficult-to-treat, locally advanced or metastatic colorectal cancer (CRC) showed no benefit on overall survival compared to Bayer’s Stivarga (regorafenib), a drug typically used in that hard-to-treat population.

In an attempt to explain the result, Roche said that the vast majority (95%) of patients in the trial had microsatellite stable (MSS) tumours – a biomarker that has previously been shown to predict a poorer response to cancer immunotherapies when used on their own because it is harder for the immune system to detect the tumour.

It’s worth noting that last year Merck & Co/MSD’s Keytruda (pembrolizumab) became the first checkpoint inhibitor to be approved for microsatellite instability-high (MSI-H) tumours, the first drug approved on the basis of a biomarker rather than where a tumour originated.

“The results from IMblaze370 were consistent with this prior monotherapy experience, showing that treatment with Tecentriq alone did not provide a meaningful clinical benefit compared to regorafenib in this patient population,” said the company.

It’s possible of course that the result would have been different if the company had restricted its recruitment to MSI-H patients, but the intention in this study was to try to find a way to treat the bulk of CRC patients with MSS that look set to be excluded from cancer immunotherapy for now.

Despite the explanation, the result casts a shadow on Roche’s extensive plans for the Tecentriq/Cotellic combination, with trials ongoing or planned  in other cancers including melanoma – with two pivotal studies called IMspire150 and IMspire170 – as well as breast, ovarian, bile duct, thyroid and other solid tumours. Some of those studies are also adding in Roche’s Avastin (bevacizumab) as a third treatment option.

“While these results are not what we hoped for, we remain committed to applying our deep experience to develop medicines that will improve outcomes for people living with gastrointestinal cancers,” said Roche’s chief medical officer Sandra Horning.

“In particular, we have a number of studies evaluating medicines in colorectal cancer that could play an important role in the treatment of people with this disease in the future,” she added.

Nevertheless, the latest failure will likely not be the last  as the pharma industry advances on all fronts in cancer immunotherapy, with a scattergun approach to testing combinations in the hope of bagging a winner.

To paraphrase Forrest Gump, running immuno-oncology trials is a bit like a box of chocolates – you never know what result you’re going to get!

Article by
Phil Taylor

13th May 2018

From: Research, Healthcare



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