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Loxo, Bayer get FDA okay for biomarker-driven cancer drug

A first for Loxo, and a second mutation-based targeted drug

Loxo Oncology has its first product approval, becoming the second company to get FDA backing for a drug that treats cancer based on a specific genetic mutation rather than its location in the body.

Vikrakvi (larotrectinib) – partnered with Bayer – has been cleared to treat any solid tumour that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion, which causes the production of TRK, a family of proteins that drives tumour growth.

Earlier this year Merck & Co/MSD became the first company to secure approval for a ‘tissue agnostic’ drug when its PD-1 inhibitor Keytruda (pembrolizumab) was backed for cancers harbouring a biomarker known as microsatellite instability - high (MSI-H).

NTRK fusions are rare –Loxo estimates that there are approximately 2,500 to 3,000 new cases of advanced NTRK fusion cancer in the US each year – so the big challenge for Loxo and Bayer will be to encourage oncologists to test for them and identify patients who may be eligible for Vikrakvi, which will launch with a premium price tag of $393,600 per year. Bayer is offering a refund however for patients who don’t see a benefit from the drug within three months.

At the moment there is no companion diagnostic for NTRK fusions so patients need to be identified through genomic profiling techniques such as immunohistochemistry or genetic sequencing approaches, which tend to be available only through specialist centres.

Josh Bilenker

Loxo's chief executive Josh Bilenker

Acknowledging the challenge, Loxo’s chief executive Josh Bilenker said: “It is now even more critical to screen patients of all ages with advanced solid tumours for actionable genomic insights that could benefit their care or aid in their referral to clinical trials.”

To try to address the diagnostic issue, Loxo formed a partnership earlier this year with Illumina to develop a simple test – called TruSight Tumour 170 – that will use sequencing to identify whether patients’ tumours carry a broad range of genomic signatures. It will also test patients for another mutation – RET fusions – that are being targeted by Loxo’s RET inhibitor LOXO-292.

Analysts at Oppenheimer are suggesting that take-up will not be a problem, however, predicting that annual sales of Vikrakvi will grow to more than $1bn by 2024, thanks to impressive results in clinical trials.

Studies have revealed that larotrectinib achieved a 75% overall response rate (ORR) in NTRK fusion cancers, including 22% complete responses, and seems to have a durable effect with the median duration of response not reached after 18 months’ follow-up.

The FDA’s approval of Vikrakvi is for NKTR fusion-positive tumours “without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity and have no satisfactory alternative treatments or that have progressed following treatment.”

Loxo has brought its drug to market ahead of main rival entrectinib from Roche, which is in late-stage testing and could be submitted for approval before the end of the year. Roche acquired the drug as part of its $1.7bn acquisition of Ignyta last year.

Bayer bought into the programme last year, agreeing to pay $400m upfront for rights to larotrectinib and a follow-up drug – LOXO-195 – that is being developed to tackle tumours that develop resistance to larotrectinib or other drugs in the TRK inhibitor class. The total value of that deal is up to $1.55bn.

A marketing application for larotrectinib was submitted to the EMA in August, setting up a potential approval in the middle of next year.

Article by
Phil Taylor

27th November 2018

From: Regulatory

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