4:59 PM
 | 
Jun 28, 2019
 |  BioCentury  |  Product Development

Why tissue-agnostic drug development needs NGS to go mainstream

For tissue-agnostic drug development to go big, NGS needs to become routine with community oncologists

Next-generation sequencing is emerging as the rate-limiting factor for how fast and broadly tissue-agnostic drug development will take off in drug development. By engaging community oncologists, some companies hope to spread the word and enable more patients access to trials earlier in their disease.

This month saw the third agent approved based on its molecular target rather than the cancer’s tissue of origin, when Japan’s Ministry of Health, Labor & Welfare granted approval to Roche’s Rozlytrek entrecitinib to treat NTRK-positive cancer.

Rozlytrek joins Bayer AG’s Vitrakvi larotrectinib, also approved for NTRK-positive cancers, and Merck & Co.’s Keytruda pembrolizumab, which was approved in May 2017 to treat MSI-H or mismatch repair deficient tumors.

“This has become a more viable approach to drug development now that we have this regulatory precedence,” said Kate Haviland, COO at Blueprint Medicines Inc.

But better efficiency in finding the right mutations to target, and the patients who carry them, is critical for wider adoption. There is still a patchwork integration of NGS in practice. How companies access and deploy the technology will shape the way tissue-agnostic drug development takes hold in cancer care.

“It’s one thing to test 100 patients to identify one who might benefit, but if you can test 10 or 15 patients and identify different mutations, then it becomes critically important,” said Alan Sandler, SVP, global head of product development oncology at the Genentech Inc. unit of Roche.

“This has become a more viable approach to drug development now we have this regulatory precedence.”

Kate Haviland, Blueprint Medicines

Some early adopters have taken advantage of the tumors where NGS is commonly used -- “anchor indications” -- and found driver mutations that are targeted by a marketed drug. That drug can then be tested in tissue-agnostic settings on patients with other tumors harboring the same mutation.

Others have used NGS data from patients who have exhausted all options, where oncologists may be trying to enroll them in a clinical trial or exploring off-label opportunities. Mutations that match compounds in development can guide companies towards trials for a tissue-agnostic indication.

The larger but harder opportunity lies in designing programs from the get-go for tissue-agnostic drug development, which means finding mutations that will serve as drivers across multiple cancer types. The challenge is in obtaining enough patient data to catch the rare mutations, and finding the mutations early enough to enroll the patients in trials or treat them once these agents are on the market....

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