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
Collaborator

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.

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
Ph1

Under a clinical collaboration agreement with Janssen, a Phase 1 clinical trial is evaluating 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.

Relapsed/ Refractory Multiple Myeloma

PHASE 1B/2 PLANNED
Ph1

Under a clinical trial agreement with Pfizer, a Phase 1b/2 clinical trial is planned to evaluate nirogacestat in combination with elranatamab, an investigational BCMA CD3 bispecific antibody, in patients with relapsed or refractory multiple myeloma.

Relapsed/ Refractory Multiple Myeloma

PHASE 1
Ph1

Under a clinical trial agreement with Allogene, a Phase 1 clinical trial is evaluating 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
Ph1

Under a clinical trial agreement with Precision BioSciences, a Phase 1 clinical trial is evaluating nirogacestat in combination with PBCAR269A, an investigational anti-B-cell maturation antigen (BCMA) allogeneic chimeric antigen receptor (CAR) T cell therapy, in patients with relapsed or refractory multiple myeloma.

Relapsed/ Refractory Multiple Myeloma

PHASE 1 PLANNED
PC

Under a clinical trial agreement with Seagen, a Phase 1 clinical trial is planned to evaluate nirogacestat in combination with SEA-BCMA, an investigational monoclonal antibody targeting B-cell maturation antigen (BCMA), 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. 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.

Pediatric Low-Grade Gliomas

PHASE 1/2
PC

In collaboration with St. Jude Children’s Research Hospital, a Phase 1/2 clinical trial is evaluating mirdametinib in children, adolescents, and young adults with low-grade glioma.

ER+ Metastatic Breast Cancer

Phase 1B/2A
Ph1

Under a company-supported investigator-initiated clinical trial agreement with Memorial Sloan Kettering Cancer Center, a Phase 1b/2a study will evaluate mirdametinib in combination with fulvestrant, a selective estrogen receptor degrader (SERD), in postmenopausal patients with estrogen receptor positive (ER+) metastatic breast cancer (mBC) harboring NF1 loss-of-function or other alterations of the MAPK pathway.

MEK1/MEK2 Mutant Solid Tumors

Phase 1B/2A
Ph1

Under a company-supported investigator-initiated clinical trial agreement with Memorial Sloan Kettering Cancer Center, a Phase 1b/2a study will evaluate mirdametinib as a monotherapy in adult patients with advanced solid cancers harboring MEK1 or MEK2 mutations.

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.

Hippo Mutant Tumors

PRECLINICAL
PC

SpringWorks is developing a portfolio of novel small molecule inhibitors of the TEA Domain (TEAD) family of transcription factors, designed for the potential treatment of biomarker-defined solid tumors driven by Hippo pathway mutations.

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