SpringWorks Therapeutics Inc.'s (SWTX:NASDAQ) lead drug candidate nirogacestat "significantly reduced risk of disease progression" and reduced symptoms in patients with desmoid tumors, as demonstrated in topline Phase 3 DeFi trial data, Wedbush analyst Dr. David Nierengarten reported in a September 12, 2022 research note.
Given these nirogacestat data and the paucity of approved treatments for desmoid tumors, Nierengarten expects SpringWorks' therapeutic to be approved for sale commercially, Nierengarten wrote.
Next, the biopharma intends to submit a new drug application for nirogacestat in this indication by year-end, and Wedbush expects it will be approved.
"We believe the overall results present a strong case for nirogacestat becoming the standard of care systemic treatment in desmoid tumors," wrote Nierengarten.
The analyst recapped the DeFi study results. The primary endpoint, improvement in progression-free survival compared to placebo (p<0.001), was achieved, with patients in all subgroups experiencing this benefit. The objective response rate was 41%, significant compared to the placebo, 8%.
Nierengarten described responses as "rapid and deep," noting many patients had their tumor shrink substantially. Five patients on nirogacestat experienced a complete response, whereas none on placebo did. The median time in the therapeutic range was 5.6 months compared to 11.1 months with a placebo.
Also, importantly, secondary endpoints of patient-reported outcomes were met in areas such as pain, DT symptoms, health-related quality of life, and physical functioning.
Nirogacestat was shown to be safe with manageable side effects; 95% of treatment-emergent adverse events were low grade.
When compared to potential competing drugs sorafenib and AL102, nirogacestat is the best, Nierengarten noted.
"In terms of efficacy, we view nirogacestat as numerically better than both sorafenib and AL102," Nierengarten wrote. "Given nirogacestat's higher objective response rate, faster time to response in rapidly progressing patients, and evidence of durable benefit that is still building, we have a hard time seeing physicians prescribing sorafenib over nirogacestat, except for nirogacestat-refractory patients."
Given these nirogacestat data and the paucity of approved treatments for desmoid tumors, Nierengarten expects SpringWorks' therapeutic to be approved for sale commercially, he wrote.
Wedbush has an Outperform rating and a $53 per share price target on SpringWorks, the current share price of which is about $30.20.
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Disclosures For Wedbush, SpringWorks Therapeutics Inc., September 12, 2022
Analyst Certification: We, David Nierengarten and Dennis Pak, certify that the views expressed in this report accurately reflect our personal opinions and that we have not and will not, directly or indirectly, receive compensation or other payments in connection with our specific recommendations or views contained in this report.
Company Specific Disclosures: 1. WS makes a market in the securities of SpringWorks Therapeutics, Inc.
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