ASH 18 比较完整的更新 BCMA CAR T

vantage的小结,本文尽可能地po本次ASH会议上披露地结果

竞争之激烈堪比CD19,先看国产部分,序号1-3,4-9是国外

1 HRAIN,为什么在第一个放图,红色,另外忽略秃头

HRAIN Biotech BCMA CAR T study: ORR 85% Med PFS 14.2 mo butpersistence only 6 mo at best. This study more comparable to US ones with morelines of tx.

2 legend biotech(文末有vantage评论)

LCAR-B38M Nanjing Legend BCMA via Wan-Hong Zhao

efficacy.Median prior lines = 3(twitter作者原话,自己体会)

3 carsgen

CARsgen BCMA CAR T cell formyeloma: ORR 100%. Median 4 lines tx. This is reminiscent of early Legend data.We should all be more patient and wait for longer FU

好讨厌这颗卤蛋啊


4 bluebird:bb21217

5 CELGENE:JCARH125

Evolvestudy of JCARH125 anti-BCMA CAR via S Mailankody. No requirement for BCMAexpression. Bridging chemo allowed

6 Celgene/MSKCC:MCARH171

BCMA expression was required in MCARH171 study

7  Celgene/Fred Hutch:FCARH143

Firstclinical study of FCARH143, anti-BCMA CAR derived from Seattle Children’s viaDamian Green. Median lines=11

8 Poseida:P-BCMA-101

P-BCMA-101 uses an icasp 9/rimiducid switch

9  Allogene/Cellectis:ALLO-715

BCMA CAR-T,rituximab off switch, KO TCR w/ Talen, CD52 lymphodepletion, Phase1 IND 2019


下面是vantage上的报道,相关部分红色标出,不再赘述,也不方便直接翻译,怕被砍。

In the event the data, presented today, raised more questions than answers, not helped by the fact that the presenter’s poor English made answering delegates’ questions virtually impossible. Worst of all, however, was the glaring fact that the presentation did not include 23% of the patients treated in this multiple myeloma trial.

Such holes do little for the credibility of an asset that is still shrouded in mystery. J&J struck its deal with Nanjing, a subsidiary of the listed Chinese contract researcher Genscript Biotech, a year ago, handing across $350m up front.

It was not long ago that it became apparent that LCAR-B38M, a bispecific CAR, targets two separate BCMA epitopes, but it is not clear whether it is the same construct that J&J has taken into a US trial under the lab code JNJ-68284528. Neither J&J nor Nanjing answered queries to clarify this and other questions as Vantage went to press.

Allegations

Trading in Genscript was briefly halted in September when an organisation calling itself Flaming Research made numerous allegations against Nanjing’s handling of the LCAR-B38M trial. These were swiftly rebutted in a detailed investor announcement.

However, the concern that the data are being parsed selectively has not entirely been allayed. The Ash update, like the Asco 2017 presentation, related to only one institution – the Second Affiliated Hospital of Xi'an Jiaotong University, in which 57 subjects have been treated.

Three other hospitals are taking part in the trial: Ruijin Hospital, Jiangsu Provincial and Shanghai Changzheng. But these centres have only ever featured at a low-key update at Ash 2017, detailing eight complete and three partial remissions among 11 patients treated in these three sites by that time.

Moreover, four patients classified as partial remitters at Asco 2017 were omitted from the analysis of responders at this year's Ash. The September rebuttal to Flaming Research stated that Nanjing had in fact dosed a total of 74 subjects with LCAR-B38M, and Nanjing today said the outstanding six fell to the three other centres.While the best responses among the 57 Jiaotong University subjects look impressive, the data are flattered by the fact that these patients were less sick relative to studies of rival BCMA CARs.

Nanjing also revealed one death, from dyspnoea in the setting of grade 2 cytokine release, that seemed to be LCAR-B38M related. Also, 14 of the 50 responders had relapsed as at the June data cut.

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