SpringWorks (SWTX) Highlights Nirogacestat Clinical Data at the 2022 ASCO Annual Meeting (earlier)
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SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, today announced initial clinical data from the Phase 1/2 study evaluating nirogacestat, SpringWorks’ investigational gamma secretase inhibitor, in combination with BLENREP (belantamab mafodotin-blmf), GSK plc’s (LSE/NYSE: GSK) antibody drug conjugate targeting B-cell maturation agent (BCMA), in patients with relapsed or refractory multiple myeloma (RRMM). In addition, SpringWorks also highlighted long-term follow-up data from a Phase 2 study sponsored by the National Cancer Institute (NCI) evaluating nirogacestat in patients with progressing desmoid tumors, which included follow-up on progression-free survival and long-term safety data.2 These data sets will be shared in poster sessions at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting, June 3-7, 2022 in Chicago.
“We are encouraged by the emerging clinical profile of nirogacestat with low-dose BLENREP given the promising efficacy and safety profile that we have seen to date, and we look forward to the maturation of the Phase 2 portion of the study in parallel with the initiation of new sub-studies to evaluate this combination with standard of care treatments in multiple myeloma,” said Saqib Islam, Chief Executive Officer of SpringWorks. “I would also like to thank the NCI for their commitment to evaluating nirogacestat in patients with progressing desmoid tumors. We were very pleased to recently report positive topline data from our Phase 3 DeFi trial and these follow-up data from the NCI-sponsored Phase 2 study provide valuable information on the long-term safety and efficacy profile of nirogacestat in desmoid tumor patients.”
Synergistic Effects of Low-Dose Belantamab Mafodotin in Combination with a Gamma-Secretase Inhibitor (Nirogacestat) in Patients with Relapsed/Refractory Multiple Myeloma (RRMM): DREAMM-5 Study (Poster # 443)
The objective of this sub-study of GSK’s DREAMM-5 platform trial (NCT04126200) is to determine if low-dose BLENREP in combination with nirogacestat results in similar efficacy with an improved ocular toxicity profile compared to single-agent BLENREP at its approved dose and schedule. The study opened with a dose-exploration (DE) arm evaluating 0.95 mg/kg BLENREP Q3W combined with 100 mg BID nirogacestat dosed continuously, and subsequently moved into a cohort expansion (CE) arm. The target enrollment for the CE arm of the study is 70 patients randomized either to BLENREP 2.5mg/kg Q3W monotherapy (control arm) or low-dose BLENREP plus nirogacestat combination using the same dose as the DE arm cohort.
The following results of the pre-planned interim analysis will be presented at ASCO:
- The study enrolled patients with relapsed or refractory multiple myeloma who have received at least 3 prior lines of therapy (median: 4.5), including an immunomodulatory agent, proteasome inhibitor, and anti-CD38 antibody. The poster being presented at ASCO includes data from a total of 24 patients treated with low-dose BLENREP + nirogacestat across the DE and CE cohorts (N=10 and N=14, respectively) and 14 patients treated with monotherapy BLENREP in the CE cohort.
- At the time of the March 4, 2022 data cut-off, the median (range) of follow-up in the low-dose BLENREP plus nirogacestat DE cohort was 34.5 weeks (5-88 weeks), with durations of response exceeding one year in some patients. Data from the CE cohorts are not yet mature with a median duration of follow-up of 12 weeks available at the time of data cut-off.
- The CE cohorts utilized the KVA ocular toxicity grading scale; Grade 3 ocular adverse events occurred in 1/14 (7%) patients in the low-dose BLENREP plus nirogacestat combination compared to 7/14 patients (50%) in the BLENREP monotherapy arm. The DE cohort utilized the CTCAE-5 ocular toxicity grading scale; the low-dose BLENREP plus nirogacestat combination demonstrated Grade 3 ocular adverse events in 2/10 (20%) patients.
- At the time of data cut-off, the objective response rate (ORR) of low-dose BLENREP plus nirogacestat across the DE and CE cohorts was 38%, with 17% of patients achieving a VGPR or better (N=24). The ORR of the BLENREP monotherapy control arm was 50%, with no patients achieving a VGPR or better (N=14).
These data will be presented in a poster discussion session at ASCO on June 4, 2022 from 5:30 - 7:00 p.m. EDT by Sagar Lonial, MD, FACP, Professor and Chair Department of Hematology and Medical Oncology, Winship Cancer Institute, Emory University.
Extended Progression-Free Survival and Long-Term Safety of Nirogacestat in Patients with Desmoid Tumors (Poster #449)
The primary objective of this open-label, NCI-sponsored Phase 2 study (NCT01981551) was to assess the RECIST 1.1-determined objective response rate of nirogacestat in patients with progressing desmoid tumors. Seventeen adult patients received 150 mg BID of nirogacestat dosed continuously.
The following results will be presented at ASCO:
- Of the 16 evaluable patients, no disease progression has been observed for any patient while on study.
- The median time on treatment for all evaluable patients was 4.4 years (range 0.17-7.99 years) with 4/16 patients remaining on treatment over 7 years. At the time of the Kummar, et. al publication,3 the median time on treatment was >25 months (range: 3-30 months), with 10/16 patients remaining on treatment as of the publication.
- The adverse event profile was generally consistent with what was previously reported by Kummar, et. al. Long-term follow-up data reported one new Grade 3 adverse event of diarrhea and one new Grade 3 adverse event of fatigue.
These data will be presented in a poster session on June 5, 2022 from 9:00a.m.-12:00p.m. EDT by Geraldine Helen O'Sullivan Coyne, MD, PhD, Developmental Therapeutics Clinic/Early Clinical Trials Development Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute.
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