Pipeline

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Preclinical Phase 1 Phase 2 Phase 3 Collaborators

Nirogacestat (Gamma Secretase Inhibitor)

Monotherapy

Adult desmoid tumors

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.

Monotherapy

Pediatric desmoid tumors

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.

+ BLENREP (belantamab mafodotin) (BCMA ADC)

Relapsed/refractory multiple myeloma

Under a global clinical trial agreement with GlaxoSmithKline, a randomized Phase 2 cohort expansion is evaluating nirogacestat in combination with BLENREP, an anti-B-cell maturation antigen (BCMA) antibody-drug conjugate (ADC), in patients with relapsed or refractory multiple myeloma, against a monotherapy control arm.

+ Teclistamab (BCMA bispecific)

Relapsed/refractory multiple myeloma

Janssen Logo

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.

+ ALLO-715 (BCMA CAR-T)

Relapsed/refractory multiple myeloma

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.

+ PBCAR269A (BCMA CAR-T)

Relapsed/refractory multiple myeloma

Precision Biosciences Logo

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.

+ SEA-BCMA (BCMA mAb)

Relapsed/refractory multiple myeloma

Seagen Logo

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.

+ Elranatamab (BCMA bispecific)

Relapsed/refractory multiple myeloma

Pfizer Logo

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.

Mirdametinib (MEK Inhibitor)

Monotherapy

Adult and pediatric NF1-associated plexiform neurofibromas

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.

+ Lifirafenib (RAF dimer inhibitor)

RAS/RAF mutant and other MAPK pathway aberrant solid tumors

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.

Monotherapy

Pediatric low-grade gliomas

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.

+ Fulvestrant (selective estrogen receptor degrader)

ER+ metastatic breast cancer

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.

Monotherapy

MEK 1/2 mutant solid tumors

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.

BGB-3245 (RAF Fusion and Dimer Inhibitor)

Monotherapy + Rational Combinations

RAF mutant solid tumors

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.

TEAD Inhibitor

Monotherapy + Rational Combinations

Hippo mutant tumors

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.

EGFR Inhibitor

Monotherapy + Rational Combinations

EGFR mutant tumors

SpringWorks is developing a portfolio of novel small molecule inhibitors of Epidermal Growth Factor Receptor (EGFR) designed for the potential treatment of EGFR-mutant lung cancers. The most advanced asset in the portfolio is in lead optimization and targets the C797S resistance mutation.

Nirogacestat (Gamma Secretase Inhibitor)

Monotherapy

Adult desmoid tumors

Phase 3 In Progress:

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.

Monotherapy

Pediatric desmoid tumors

Phase 2 In Progress:

Collaborators:

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.

+ BLENREP (belantamab mafodotin) (BCMA ADC)

Relapsed/refractory multiple myeloma

Phase 2 In Progress:

Collaborators:

Under a global clinical trial agreement with GlaxoSmithKline, a randomized Phase 2 cohort expansion is evaluating nirogacestat in combination with BLENREP, an anti-B-cell maturation antigen (BCMA) antibody-drug conjugate (ADC), in patients with relapsed or refractory multiple myeloma, against a monotherapy control arm.

+ Teclistamab (BCMA bispecific)

Relapsed/refractory multiple myeloma

Phase 1 In Progress:

Collaborators:

Janssen Logo

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.

+ ALLO-715 (BCMA CAR-T)

Relapsed/refractory multiple myeloma

Phase 1 In Progress:

Collaborators:

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.

+ PBCAR269A (BCMA CAR-T)

Relapsed/refractory multiple myeloma

Phase 1 In Progress:

Collaborators:

Precision Biosciences Logo

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.

+ SEA-BCMA (BCMA mAb)

Relapsed/refractory multiple myeloma

Phase 1 Planned:

Collaborators:

Seagen Logo

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.

+ Elranatamab (BCMA bispecific)

Relapsed/refractory multiple myeloma

Phase 1 Planned:

Collaborators:

Pfizer Logo

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.

Mirdametinib (MEK Inhibitor)

Monotherapy

Adult and pediatric NF1-associated plexiform neurofibromas

Phase 2 In Progress:

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.

+ Lifirafenib (RAF dimer inhibitor)

RAS/RAF mutant and other MAPK pathway aberrant solid tumors

Phase 1 In Progress:

Collaborators:

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.

Monotherapy

Pediatric low-grade gliomas

Phase 1 In Progress:

Collaborators:

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.

+ Fulvestrant (selective estrogen receptor degrader)

ER+ metastatic breast cancer

Phase 1 In Progress:

Collaborators:

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.

Monotherapy

MEK 1/2 mutant solid tumors

Phase 1 In Progress:

Collaborators:

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.

BGB-3245 (RAF Fusion and Dimer Inhibitor)

Monotherapy + Rational Combinations

RAF mutant solid tumors

Phase 1 In Progress:

Collaborators:

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.

TEAD Inhibitor

Monotherapy + Rational Combinations

Hippo mutant tumors

Pre-Clinical:

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.

EGFR Inhibitor

Monotherapy + Rational Combinations

EGFR mutant tumors

Pre-Clinical:

SpringWorks is developing a portfolio of novel small molecule inhibitors of Epidermal Growth Factor Receptor (EGFR) designed for the potential treatment of EGFR-mutant lung cancers. The most advanced asset in the portfolio is in lead optimization and targets the C797S resistance mutation.

Our pipeline

SpringWorks Therapeutics is advancing a diversified pipeline of targeted oncology programs as both standalone and combination therapies. Our development programs include late-stage rare oncology programs as well as multiple programs addressing highly prevalent, genetically defined cancers. Our team is working with urgency on behalf of the patients living with these devastating illnesses.

Let’s unlock the future of targeted oncology

We are meticulous about the science and passionate about its possibilities. This leads us to dig deeper – to explore the full potential of our molecules. You can see that approach in our pipeline. We have a diversified targeted oncology portfolio that includes standalone and combination therapies across various stages of development, including late-stage clinical trials in rare tumor types and multiple programs addressing highly prevalent, genetically defined cancers.