- HC Wainwright points out that investors are enthusiastic about SpringWorks Therapeutics Inc nirogacestat clinical profile for desmoid tumors after the R&D day held last week.
- As per a survey of U.S. oncologists treating patients with desmoid tumors, roughly 80% and 87% of medical oncologists believe that nirogacestat compares favorably to Bayer AG's
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Nexavar (sorafenib) and that they are willing to switch current patients to nirogacestat, respectively. - The analysts forecast nirogacestat achieving a peak penetration rate of 25% and 65% in the front-line and second-line desmoid tumor setting, respectively.
- They anticipate submitting an FDA marketing application for nirogacestat in desmoid tumors in 2H22.
- Moving to SpringWorks' earlier stage pipeline, the management also provided initial results for mirdametinib combined with lifirafenib, BeiGene Ltd's
- Most clinical responses came from patients with low-grade serous ovarian carcinoma with MAPK activating mutations, with a 73% ORR and a 100% disease control rate.
- HC Wainwright reiterates a Buy rating on SpringWorks Therapeutics.
- Gracell Biotechnologies Inc announced the updated clinical data on GC012F, an autologous CAR-T therapeutic candidate dual-targeting B-cell maturation antigen (BCMA) and CD19, for relapsed/refractory multiple myeloma (RRMM).
- From October 2019 to January 2022, 29 heavily pretreated patients were enrolled and treated with a single infusion of GC012F at three dose levels (DL).
- At the data cutoff of June 8, 2022, the response rate at different dose levels was 100% (2/2) in DL1, 80% (8/10) in DL2, and 100% (17/17) in DL3.
- All 29 patients achieved minimal residual disease (MRD) negativity. 75.9% of all patients treated achieved MRD-sCR. At the data cutoff, the median duration of response (DOR) was 15.7 months.
- The safety profile of GC012F was consistent with previous findings with a primarily low grade of cytokine release syndrome (CRS).
- Additionally, Gracell presented the first results of Phase 1 investigator-initiated study in China of GC012F in B-cell non-Hodgkin's lymphoma patients.
- All three patients achieved a complete response (CR) confirmed at day 28 after GC012F infusion.
- At the 3-month follow-up, both assessable patients had an ongoing response. No dose-limiting toxicities and immune effector cell-associated neurotoxicity syndrome were observed.
- CRS presented as Grade 1 in two patients and Grade 3 in one patient with no Grade 4 or 5 events.
