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Armed with new data, BMS plans filings for Celgene CAR-T liso-cel

Achieved a 53% complete response rate in study participants

Bristol-Myers Squibb logo

Shortly after closing its takeover of Celgene, Bristol-Myers Squibb has reported a positive trial for liso-cel, one of the CAR-T therapies it acquired as part of the $74bn deal.

The pivotal phase 1 data – reported at ASH – shows that liso-cel or lisocabtagene maraleucel achieved a 53% complete response rate in patients with relapsed/refractory large B-cell lymphomas, setting up regulatory filings later this month.

Overall, 73% of patients in the TRANSCEND NHL 001 study had either a complete or partial response to liso-cel, a CD19-targeted CAR-T which – if approved – would be a third-to-market competitor to Novartis’ Kymriah (tisagenlecleucel) and Gilead Sciences Yescarta (axicabtagene ciloleucel).

The median duration of response has not been reached after follow-up of 12 months, and 60.4% and 54.7% of patients remained in response at six and 12 months, respectively.

The efficacy data looks similar on paper to the two approved CAR-Ts, though in a much larger group of patients, and BMS is also hoping to compensate for being a late entrant into the market with a strong safety profile.

On that front, liso-cel looked pretty good, with low rates of serious (grade 3 or higher) cytokine release syndrome and neurotoxicity – affecting 2% and 10% of patients, respectively – and which could potentially mean the therapy could be given on an outpatient basis.

Rates of serious adverse reactions in other CAR-T trials have tended to be 20-40% for CRS and 10-30% for neurotoxicity. Both side effects can be life-threatening and in some cases even fatal.

There were eight deaths in the liso-cel trial, including four linked to the treatment, but it is well recognised that CAR-T procedures carry significant risks and are used in patients who have generally exhausted other treatment options.

One area of concern was that there were 25 patients who received a CAR-T product that didn’t meet standards, and two manufacturing failures, together accounting for around 10% of the evaluable patient group at ASH.

Before being taken over, Celgene had suggested that liso-cel (formerly JCAR017) had the potential to become a $3bn product.

That would be a phenomenal success for the latecomer. Despite being approved in 2017, Kymriah had sales of $182m in the first nine months of the year from its use in acute lymphoblastic leukaemia (ALL) and diffuse large B-cell lymphoma (DLBCL).

Meanwhile, in the same period Yescarta brought in $183m from its use in DLBCL and other B-cell lymphoma types.

Getting approval for the CAR-T is also a critical component of a potential payout of $6bn in contingent value rights associated with the BMS takeover, so the new data will have sparked celebrations among former Celgene shareholders.

Liso-cel is one of three drugs tied to the CVR payments, and to qualify will have to secure FDA approval by the end of next year.

Article by
Phil Taylor

9th December 2019

From: Research

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