Pipeline

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.

Program
Indication
  • Preclinical
  • Phase 1
  • Phase 2
  • Phase 3
phase
Partner/ Collaborator

Desmoid Tumors: Adult Study

PHASE 3
Ph3

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.

Desmoid Tumors: Pediatric Study

PHASE 2
Ph2

In collaboration with Children’s Oncology Group (COG), a Phase 2 clinical trial is evaluating nirogacestat in children and adolescents with progressive, surgically unresectable desmoid tumors.

Relapsed/ Refractory Multiple Myeloma

PHASE 1B
Ph1

Under a global clinical trial agreement with GlaxoSmithKline, a Phase 1b clinical trial is evaluating nirogacestat in combination with BLENREP (belantamab mafodotin-blmf), an anti-B-cell maturation antigen (BCMA) antibody-drug conjugate (ADC), in patients with relapsed or refractory multiple myeloma.

Relapsed/ Refractory Multiple Myeloma

PHASE 1 PLANNED
Ph1

Under a clinical trial agreement with Allogene, a Phase 1 clinical trial is planned to evaluate nirogacestat in combination with ALLO-715, an investigational anti-B-cell maturation antigen (BCMA) AlloCAR T therapy, in patients with relapsed or refractory multiple myeloma.

Relapsed/ Refractory Multiple Myeloma

PHASE 1 PLANNED
Ph1

Under a clinical collaboration agreement with Janssen, a Phase 1 clinical trial is planned to evaluate nirogacestat in combination with teclistamab, an investigational bispecific antibody targeting B-cell maturation antigen (BCMA) and CD3, in patients with relapsed or refractory multiple myeloma.

NF1-Associated Plexiform Neurofibromas (PN)

PHASE 2B
Ph2

Neurofibromatosis type 1-associated plexiform neurofibromas (NF1-PN) is a rare tumor of the peripheral nerve sheath that causes significant pain and disfigurement. NF1-PN most often manifests in children. Mirdametinib is in a Phase 2b trial (“ReNeu”) for children and adults with inoperable NF1-PN, and has received Orphan Drug and Fast Track Designations for this indication. Learn more about mirdametinib.

RAS/RAF Mutant Solid Tumors

PHASE 1B/2
Ph1

Under a collaboration agreement with BeiGene, a Phase 1b/2 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

PHASE 1
Ph1

BGB-3245 is a novel oral, selective small molecule inhibitor of monomer and dimer forms of activating B-RAF mutations including V600 B-RAF mutations, non-V600 B-RAF mutations and RAF fusions. BGB-3245 is being advanced by MapKure, an entity jointly owned by SpringWorks and BeiGene. A Phase 1 clinical trial is evaluating BGB-3245 in patients with advanced or refractory solid tumors including those with B-RAF driver mutations and fusions that are likely to respond to a RAF dimer inhibitor.

* Being developed by MapKure, LLC, or MapKure, an entity jointly owned by SpringWorks and BeiGene.