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ASH18: CAR-T and drugs give new options for multiple myeloma

San Diego congress showcasing data in important haematology markets

Celgene and Bluebird Bio’s anti-BCMA CAR-T bb21217 is effective in patients with very advanced multiple myeloma, and crucially seems to persist in the body longer than its first-generation predecessor.

The new data revealed at the American Society of Haematology (ASH) congress in San Diego showed that bb21217 achieved an overall response rate (ORR) of 83% in 12 heavily pre-treated patients with relapsed/refractory myeloma at the first dose level studied, with a second, higher dose still to be tried.


Celgene needs to maintain its dominance in myeloma with novel agents

The two companies are walking a tightrope with bb21217, hoping to show that it can maintain a more durable response than their first-generation anti-BCMA bb2121, but not completely overshadow the older drug which isn’t expected be filed for approval until next year.

bb21217 has been engineered to improve the ‘functional persistence’ of the CAR-T cells in the body, after data with bb2121 suggested that despite a very high ORR of 96% - including 50% complete responses – the median time to progression was less than a year.

The data with bb21217 gives an indication of greater persistence, with the cells still detectable in all three patients who had passed the six month time point after the CAR-T therapy was first administered. However, the top-line efficacy seems a little lower than bb2121 at this early stage, with three of 10 responders have a complete or stringent complete response.

On the safety front, eight of the 12 patients treated with bb21217 developed cytokine release syndrome, the side effect that caused most issues with the first CAR-Ts to reach the market, while three of the patients experienced neurotoxicity. Analysts at William Blair suggest that neurotoxicity could be a big factor separating anti-BCMA therapies, as clinicians are becoming more adept at using drugs to handle CRS.

There will be plenty of additional news on CAR-T therapies for myeloma at ASH this year. Later today, Johnson & Johnson will present new  phase 1 data on its early-stage anti-BCMA CAR-T LCAR-B38M in relapsed myeloma, after revealing a 100% response rate at an earlier timepoint, and Celgene is due to report results on no fewer than three anti-BCMA CAR-Ts developed by Juno – namely JCARH125, MCARH171 and FCARH143.

Drug therapies

There was also plenty of new data available on drug therapies for myeloma, notably Takeda’s proteasome inhibitor Ninlaro (ixazomib) which looks on course to claim a new indication as a maintenance therapy for the disease, after cutting the risk of disease progression or death by 28% compared to placebo in adult patients who’ve already been treated with high-dose chemo and undergone an autologous haematopoietic stem cell transplant (HSCT).


Ninlaro is already approved as a second-line therapy in combination with Celgene’s Revlimid (lenalidomide) and dexamethasone, and Takeda is also trying to move its drug into the first-line setting to rival J&J’s anti-CD38 antibody Darzalex (daratumumab). The new data at ASH – from the TOURMALINE-MM3 study – will be submitted to regulators in the hope of extending the use of the drug into the maintenance setting.

J&J also reported new trial results for Darzalex in newly-diagnosed myeloma patients, showing in the ALCYONE trial that adding the drug to chemotherapy in patients ineligible for HSCT reduced the risk of disease progression or death by 57% compared to chemo alone after a median follow up of almost 28 months.

Later today, Amgen will report additional data from a trial of AMG 420, its anti-BCMA bispecific T-cell engager (BiTE) antibody construct that in early readouts has revealed impressive results – five complete responses in five patients – that could pose a threat to the BCMA-targeting CAR-Ts.

There are also updates expected on  GlaxoSmithKline’s anti-BCMA antibody-drug conjugate (ADC) GSK2857916 and Pfizer’s bispecific antibody PF-06863135.

Article by
Phil Taylor

3rd December 2018

From: Research



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