SpringWorks Therapeutics is advancing a diversified pipeline of targeted oncology programs being evaluated as standalone and combination therapies. Our development programs include two potentially registrational clinical trials in rare tumor types as well as several other programs addressing highly prevalent, genetically defined cancers. Our team is working with urgency on behalf of the underserved patients living with these devastating illnesses.
- Phase 1
- Phase 2
- Phase 3
Desmoid tumors are rare and often debilitating and disfiguring soft tissue tumors for which there are currently no FDA-approved therapies. Nirogacestat is in a Phase 3 clinical trial (“DeFi”) for patients with desmoid tumors and has received Orphan Drug Designation, Fast Track and Breakthrough Therapy Designations for this indication. Learn more about nirogacestat.
Relapsed/ Refractory Multiple Myeloma
Under a global clinical trial agreement with GlaxoSmithKline, a Phase 1b clinical trial is planned to evaluate nirogacestat in combination with belantamab mafodotin, an anti-B-cell maturation antigen (BCMA) antibody-drug conjugate (ADC), in patients with relapsed or refractory multiple myeloma.
Neurofibromatosis type 1-associated plexiform neurofibromas (NF1-PN) is a rare tumor of the peripheral nerve sheath that causes significant pain and disfigurement, and for which there are no FDA-approved therapies. NF1-PN most often manifests in children. SpringWorks expects to initiate a Phase 2b clinical trial of mirdametinib (“ReNeu”) in the third quarter of 2019. Mirdametinib received Orphan Drug and Fast Track Designations for this indication. Learn more about mirdametinib.
RAS/RAF Mutant Solid Tumors
Under a collaboration agreement with BeiGene, a Phase 1b clinical trial is evaluating mirdametinib in combination with lifirafenib, BeiGene’s RAF dimer inhibitor, in patients with advanced or refractory solid tumors harboring RAS mutations, RAF mutations, and other MAPK pathway aberrations.
RAF Mutant Solid Tumors
BGB-3245 is a novel oral, selective small molecule inhibitor of specific BRAF driver mutations and genetic fusions. BGB-3245 is being advanced by MapKure, a newly formed entity jointly owned by SpringWorks and BeiGene.
* Being developed by MapKure, LLC, or MapKure, a newly formed entity jointly owned by SpringWorks and BeiGene.