SpringWorks (SWTX) Down Despite Desmoid Tumors Study Meeting Goal
SpringWorks Therapeutics, Inc. SWTX announced the phase III DeFi study, which evaluated its investigational gamma-secretase inhibitor, nirogacestat, for treating adult patients with progressing desmoid tumors, has met the primary and all key secondary endpoints.
Data from the study showed that treatment with nirogacestat led to a statistically significant improvement in progression-free survival (PFS) — the study’s primary endpoint — versus placebo, with a 71% reduction in the risk of disease progression –
Treatment with nirogacestat also led to significant improvements in objective response rate (ORR) and patient-reported outcomes compared with placebo, which was the study’s secondary endpoints.
Nirogacestat was generally well tolerated in the study and had a manageable safety profile.
SpringWorks plans to file a new drug application to the FDA for nirogacestat to treat desmoid tumors, a rare, aggressive tumor of the soft tissues, in the second half of 2022.
Despite the positive data from the above-mentioned study, shares of SpringWorks were down 11.4% on Tuesday following the news. The stock has plunged 45.7% so far this year compared with the industry’s decline of 23.5%.
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We note that five studies are currently evaluating nirogacestat in combination with investigational B-cell maturation antigen’s (BCMA) of several big drugmakers for treating relapsed or refractory multiple myeloma.
In April 2022, SpringWorks entered into a collaboration with Regeneron Pharmaceuticals REGN to evaluate nirogacestat in combination with the latter’s investigational bispecific antibody targeting BCMA and CD3 — REGN5458 — for treating relapsed or refractory multiple myeloma.
Per the deal, REGN will be solely responsible for the clinical development and assume all costs related to the study.
SpringWorks is also planning to evaluate nirogacestat in combination with Seagen’s investigational monoclonal antibody targeting BCMA – SEA-BCMA and AbbVie’s ABBV investigational CD3 bispecific antibody directed against BCMA, ABBV-383 for treating relapsed or refractory multiple myeloma.
Last December, SpringWorks entered into a collaboration agreement with AbbVie to evaluate nirogacestat in combination with ABBV-383 for the treatment of patients with relapsed or refractory multiple myeloma. A phase Ib study is expected to begin later in 2022.
The combination studies with Regeneron, Seagen and AbbVie are expected to begin at a later date.
Zacks Rank & Stock to Consider
SpringWorks currently carries a Zacks Rank #4 (Sell).
A better-ranked stock in the biotech sector is Leap Therapeutics, Inc. LPTX, which carries a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
The Zacks Consensus Estimate for Leap Therapeutics’ loss per share has narrowed 11.1% for 2022 and 5.9% for 2023 over the past 60 days.
Earnings of Leap Therapeutics have surpassed estimates in three of the trailing four quarters and missed the same on the other occasion. LPTX delivered an earnings surprise of 1.92%, on average.
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