Geen illusies....over de sultan.....
En 100% respons gaat over J&J....
This year’s Ash features numerous duelling anti-BCMA therapies in multiple myeloma, and the first clinical data for JNJ-4528 impress.
Ash attendees milling around
With Bluebird missing the deadline for getting its registrational Karmma dataset into the Ash conference, the way was left clear for Johnson & Johnson to seize the early spotlight. Today’s Ash presentation of the first human data with J&J’s anti-BCMA Car-T project JNJ-4528 has shown a staggering 100% remission rate.
Bluebird/Bristol-Myers Squibb did unveil the Karmma data yesterday, but only by press release. The results certainly seem good enough to secure approval for ide-cel/bb2121 in late-line multiple myeloma, but relapses remain the elephant in the room, and care has to be taken when attempting cross-study comparisons owing to differing patient characteristics.
In Karmma, for instance, all 128 treated subjects had failed at least three therapy lines, and 84% were triple-refractory. The key efficacy data – a 73.4% overall response rate, including 31.3% complete remissions – look reasonable compared with the 77% ORR (31% CR) rates seen in the earlier study of bb2121 in subjects who had failed an average seven prior therapies.
However, the worry is relapses: remissions in Karmma lasted only 10.6 months on average, and median progression-free survival was 8.6 months. Against such a backdrop, the threat of J&J’s JNJ-4528 in what is already a highly competitive field has suddenly become real.
At Ash today J&J said its Cartitude-1 trial of JNJ-4528 had so far treated 29 subjects, 86% of whom were triple-refractory, and 31% of whom were penta-refractory. All patients responded to JNJ-4528, an amazing 69% showing complete remission or better..........