Loxo Oncology has been one of the pioneers in the move to develop new, tissue-agnostic cancer drugs. But the biggest challenge it faces won’t be in the clinic. Instead analysts will be trying to determine the extent to which fairly expensive diagnostic testing will be used to spotlight their tiny patient population.
Bloomberg took a look at the issue in an in-depth report today, comparing the work that Loxo’s partner Bayer will have in popularizing these tests, which can cost thousands of dollars each, screening broad groups to find the one in 100 that need their drug. Roche, meanwhile, which has been a huge advocate of matching diagnostics to drugs, just spent $2.4 billion to acquire the last chunk of stock in the cancer diagnostics player Foundation Medicine it didn’t already own.
And Roche — which highlighted its plans for developing better tests that can provide genomic profiling on cancer patients — has a rival drug in the clinic that it hopes can take on Loxo and Bayer’s leading therapy. Roche bagged entrectinib late last year in its $1.7 billion Ignyta buyout, looking to cut in line with a therapy now in an accelerated development program.
The Bloomberg writers highlight one of the ironies in this situation. Roche’s advanced diagnostics work may initially play out in favor of their rivals, as Loxo and Bayer are expected to get out of the gate first with larotrectinib, identifying patients with rare NTRK fusion-positive tumors. Loxo also impressed the industry a few weeks ago at ASCO, as their second drug aimed at RET fusion-positive cases also produced promising early data, possibly pointing them down another short stretch at the FDA.
Loxo CEO Josh Bilenker, though, says the more personalized drugs hit the market, requiring physicians at both academic and community centers to profile their patients individual quirks, the merrier it will be for everyone.
“The more therapies you have lining up, on the shelf,” Josh Bilenker told me at ASCO, “the more impetus to screen broadly everybody.”
His commercial success depends on it.
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