Gracell to Open an R&D Facility in the US; JPM 2022 Days 2 & 3: Legend, Allogene, and Autolus
A series of cell therapy-related news items have been observed:
A series of cell therapy-related news items have been observed:
On Monday, December 13, Legend held their investor event highlighting updated clinical results from Carvykti’s (BCMA CAR-T; cilta-cel) Ph1b/2 CARTITUDE-1 and Ph2 CARTITUDE-2 studies in r/r MM. Below, Celltelligence provides insights on Carvykti’s improved efficacy profile compared to real-world clinical practice (RWCP) in r/r MM, while discussing whether a GSI combination is necessary to improve a BCMA CAR-T’s efficacy.
On Monday, December 13, the CHMP agenda for December was released. Of note, Kymriah’s (Novartis’s CD19 CAR-T) Type II variation for r/r FL is listed as ‘For Adoption’, while Carvykti (JNJ / Legend’s BCMA CAR-T; cilta-cel) is displayed under the ‘List of outstanding issues (LoOI)’ section. Moreover, Tecartus (Gilead’s / Kite’s CD19 CAR-T) and Breyanzi (BMS’s CD19 CAR-T) were absent from December’s CHMP agenda. Below, Celltelligence provides insights on potential EU approval timelines for Kymriah and Carvykti, while discussing possible causes for Tecartus’s and Breyanzi’s regulatory delays.
On the second day of ASH 2021, 3 clinical updates were presented by BMS, 2seventy, and Legend. Below, Celltelligence provides insights and context for each presentation.
On Monday, December 6, Legend announced (press release) that they have submitted Carvykti’s NDA (cilta-cel; BCMA CAR-T) to Japan’s Ministry of Health Labour and Welfare (MHLW) for the treatment of r/r MM. Below, Celltelligence provides insights on a likely approval timeline for Carvkyti in Japan.
On Tuesday, November 16, Legend released their Q3 2021 financial updates (press release) highlighting that enrollment for cilta-cel’s (BCMA CAR-T) Ph3 CARTITUDE-4 study in 2-4L r/r MM has completed, while discussing cilta-cel’s FDA and PMDA regulatory updates. Additionally, management announced the development of LCAR-AIO, a novel tri-specific CD19 x CD20 x CD22 CAR-T for treating B-cell malignancies following CAR-T therapy relapse. Below, Celltelligence provides insights on when Legend / JNJ could potentially file cilta-cel’s sBLA in 2L r/r MM based on data from CARTITUDE-4, while discussing Legend’s novel tri-specific CAR-T and pipeline updates.
On Monday, November 8, the CHMP agenda for November was released. Of note, Yescarta’s (Gilead’s CD19 CAR-T) Type II variation for ≥4L r/r FL is listed as ‘For Adoption’, while no updates were observed for Tecartus (Gilead’s CD19 CAR-T) in r/r adult ALL and cilta-cel (JNJ / Legend’s BCMA CAR-T) in r/r MM. Below, Celltelligence provides likely EU approval timelines for Yescarta, Tecartus, and cilta-cel.
After market close today, November 1, 2021, Legend announced the PDUFA delay for cilta-cel to February 28, 2022, a delay of 3 months from the original action date of November 29, 2021. The news comes on the heels of bullish commentary from Legend’s October 18 R&D day (see previous insight) and JNJ’s Q3 2021 earnings on October 21 (see previous insight).
On Wednesday, October 27, BMS held their Q3 2021 earnings presentation (press release / presentation) highlighting Breyanzi’s (CD19 CAR-T) and Abecma’s (BCMA CAR-T) continued revenue growth. Furthermore, management commented that Abecma’s vector supply issues may not be fully resolved before H2 2022. On the same day, GSK presented their Q3 2021 financial results (press release / presentation). However, the company did not provide any updates on their cell therapy assets in development.
On Thursday, October 21, FiercePharma published an article (publication) discussing cilta-cel’s launch strategy with Serge Messerlian, Janssen’s US Oncology President. Messerlian commented on JNJ’s / Legend’s plan to develop a digital platform for cilta-cel (BCMA CAR-T) while confirming that cilta-cel and Darzalex (JNJ’s CD38 antibody for r/r MM; daratumumab) will have separate sales teams. Below, Celltelligence provides insights on how JNJ / Legend could leverage Darzalex’s patient-focused digital platform and sales force team to increase patient referrals for cilta-cel upon approval.