Drug Development

Spurring move to personalized therapies, Loxo elbows its way back into the ASCO spotlight with 2nd tissue-agnostic cancer drug success

CHICAGO — With their lead drug — and ASCO17 star — larotrectinib making the final run-up to a widely expected approval in November, Loxo Oncology $LOXO is back at the big cancer conference this year with its next drug in the pipeline. And LOXO-292 is blazing a trail of positive early-stage data that may well foretell another breakthrough for the biotech’s tissue-agnostic approach to cancer drug development.

In their first definitive snapshot on the interim data, investigators at Loxo unveiled a 77% overall response rate for RET fusion-positive cases, handily beating the ASCO preview figure of 69% as promised. In RET-mutant medullary thyroid cancer the rate dropped to 45%.

Most of the RET-fusion patients (38) — threatened by uncontrolled cell growth — were in the non-small cell lung cancer group, but investigators also had 9 patients with thyroid cancer and 2 with pancreatic cancer.

Josh Bilenker


Loxo CEO Josh Bilenker tells me that “LOXO-292 is a highly active drug, with a meaty Phase I experience. It shows the drug has a very high overall response rate in RET fusion.” 

And it’s also a candidate for fast-track development, he adds, with a shot at a greatly accelerated approval pathway — much like larotrectinib.

“Its a pretty heavily pretreated population,” adds chief business officer Jake Van Naarden about the initial data round. “Many patients have seen a prior kinase inhibitor and nearly everyone had prior systemic therapy. To see this kind of activity in that patient population is encouraging.”

Loxo has established an early lead over Blueprint Medicines $BPMC, has been advancing the rival RET-targeted BLU-667, which has been attracting warm reviews by analysts — unless they start comparing it to the rival.

Jacob S. Van Naarden


Loxo’s longterm success lies in the growing movement to use genetic sequencing to ID the specific mutations that drive the success of their therapies. Sequencing, says the CEO, is “becoming a mainstay of clinical practice,” as physicians look to match patients with the best therapies for their particular cancer type. As personalized medicine in oncology becomes increasingly common, they’ll be able to identify more patients who can benefit from their therapies — and then they’ll be able to capitalize more on their work.

“The more therapies you have lining up, on the shelf,” says Bilenker, “the more impetus to screen broadly everybody.”

To help push that trend in their favor, Loxo recently signed on with the giant Illumina to develop a companion diagnostic that could be used to screen patients who would benefit from both larotrectinib as well LOXO-292.


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