Pipeline

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Let’s go big.

Preclinical Phase 1 Phase 2 Phase 3 Regulatory Submission Approved Collaborators

Nirogacestat (Gamma Secretase Inhibitor)

Monotherapy

Adult desmoid tumors

Approved in the U.S.

Approved in the U.S. for the treatment of adult patients with progressing desmoid tumors who require systemic treatment.

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.

Monotherapy

Ovarian Granulosa Cell Tumors

Ovarian granulosa cell tumors are a rare ovarian cancer subtype for which there are currently no FDA-approved therapies. SpringWorks is conducting a Phase 2 study of nirogacestat in recurrent ovarian granulosa cell tumors.

+ Blenrep-belantamab mafodotin (belamaf) (BCMA ADC)

Relapsed/refractory multiple myeloma

GSK logo

A Phase 2 randomized DREAMM-5 study is ongoing evaluating low-dose belamaf in combination with nirogacestat in patients with relapsed or refractory multiple myeloma. In addition, two new sub-studies evaluating belamaf plus nirogacestat in combination with standard of care agents in patients with relapsed or refractory multiple myeloma have been initiated and are dosing patients: sub-study 6 (belamaf plus nirogacestat plus lenalidomide plus dexamethasone) and sub-study 7 (belamaf plus nirogacestat plus pomalidomide plus dexamethasone).

+ 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.

+ Elranatamab (BCMA bispecific)

Relapsed/refractory multiple myeloma

Pfizer Logo

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

+ Linvoseltamab (BCMA bispecific)

Relapsed/refractory multiple myeloma

Under a clinical trial collaboration and supply agreement with Regeneron, a Phase 1b clinical trial is planned to evaluate nirogacestat in combination with linvoseltamab (REGN5458), an investigational BCMAxCD3 bispecific antibody, in patients with relapsed or refractory multiple myeloma.

+ ABBV-383 (BCMA bispecific)

Relapsed/refractory multiple myeloma

Under a clinical agreement with AbbVie, a Phase 1b clinical trial is planned to evaluate nirogacestat in combination with ABBV-383, an investigational CD3 bispecific antibody directed against B-cell maturation agent (BCMA), 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.

Monotherapy

Pediatric low-grade gliomas

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

+ 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.

Brimarafenib (BGB-3245) (RAF Fusion and Dimer Inhibitor)

Monotherapy

MAPK mutant solid tumors

Brimarafenib 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. A Phase 1 clinical trial is evaluating brimarafenib 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. Brimarafenib is being developed by MapKure, LLC, a joint venture between SpringWorks and BeiGene.

+ Mirdametinib

MAPK mutant solid tumors

A Phase 1/2a combination study is evaluating brimarafenib, a selective RAF dimer inhibitor, in combination with mirdametinib, a MEK inhibitor, in patients with MAPK mutant solid tumors. Brimarafenib is being developed by MapKure, LLC, a joint venture between SpringWorks and BeiGene.

+ Panitumumab

MAPK mutant solid tumors

MapKure will conduct a Phase 1b study of brimarafenib with panitumumab, a monoclonal antibody targeting EGFR, in colorectal and pancreatic cancer patients with known MAPK pathway mutations.

SW-682 (TEAD Inhibitor)

Monotherapy + Rational Combinations

Hippo mutant tumors

SpringWorks is developing SW-682 , a novel small molecule inhibitor of the TEA Domain (TEAD) family of transcription factors, for the potential treatment of biomarker-defined solid tumors driven by Hippo pathway mutations.

Nirogacestat (Gamma Secretase Inhibitor)

Monotherapy

Adult desmoid tumors

Regulatory Approval

Approved in the U.S. for the treatment of adult patients with progressing desmoid tumors who require systemic treatment.

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.

Monotherapy

Ovarian Granulosa Cell Tumors

Phase 2 In Progress:

Ovarian granulosa cell tumors are a rare ovarian cancer subtype for which there are currently no FDA-approved therapies. SpringWorks is conducting a Phase 2 study of nirogacestat in recurrent ovarian granulosa cell tumors.

+ Blenrep-belantamab mafodotin (belamaf) (BCMA ADC)

Relapsed/refractory multiple myeloma

Phase 2 In Progress:

Collaborators:

GSK logo

A Phase 2 randomized DREAMM-5 study is ongoing evaluating low-dose belamaf in combination with nirogacestat in patients with relapsed or refractory multiple myeloma. In addition, two new sub-studies evaluating belamaf plus nirogacestat in combination with standard of care agents in patients with relapsed or refractory multiple myeloma have been initiated and are dosing patients: sub-study 6 (belamaf plus nirogacestat plus lenalidomide plus dexamethasone) and sub-study 7 (belamaf plus nirogacestat plus pomalidomide plus dexamethasone).

+ 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.

+ Elranatamab (BCMA bispecific)

Relapsed/refractory multiple myeloma

Phase 1 In Progress:

Collaborators:

Pfizer Logo

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

+ Linvoseltamab (BCMA bispecific)

Relapsed/refractory multiple myeloma

Phase 1 In Progress:

Collaborators:

Under a clinical trial collaboration and supply agreement with Regeneron, a Phase 1b clinical trial is planned to evaluate nirogacestat in combination with linvoseltamab (REGN5458), an investigational BCMAxCD3 bispecific antibody, in patients with relapsed or refractory multiple myeloma.

+ ABBV-383 (BCMA bispecific)

Relapsed/refractory multiple myeloma

Pre-Clinical In Progress:

Collaborators:

Under a clinical agreement with AbbVie, a Phase 1b clinical trial is planned to evaluate nirogacestat in combination with ABBV-383, an investigational CD3 bispecific antibody directed against B-cell maturation agent (BCMA), 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.

Monotherapy

Pediatric low-grade gliomas

Phase 2 In Progress:

Collaborators:

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

+ 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.

Brimarafenib (BGB-3245) (RAF Fusion and Dimer Inhibitor)

Monotherapy

MAPK mutant solid tumors

Phase 1 In Progress:

Collaborators:

Brimarafenib 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. A Phase 1 clinical trial is evaluating brimarafenib 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. Brimarafenib is being developed by MapKure, LLC, a joint venture between SpringWorks and BeiGene.

+ Mirdametinib

MAPK mutant solid tumors

Phase 1 In Progress:

Collaborators:

A Phase 1/2a combination study is evaluating brimarafenib, a selective RAF dimer inhibitor, in combination with mirdametinib, a MEK inhibitor, in patients with MAPK mutant solid tumors. Brimarafenib is being developed by MapKure, LLC, a joint venture between SpringWorks and BeiGene.

+ Panitumumab

MAPK mutant solid tumors

Phase 1 In Progress:

Collaborators:

MapKure will conduct a Phase 1b study of brimarafenib with panitumumab, a monoclonal antibody targeting EGFR, in colorectal and pancreatic cancer patients with known MAPK pathway mutations.

SW-682 (TEAD Inhibitor)

Monotherapy + Rational Combinations

Hippo mutant tumors

Pre-Clinical In Progress:

SpringWorks is developing SW-682 , a novel small molecule inhibitor of the TEA Domain (TEAD) family of transcription factors, for the potential treatment of biomarker-defined solid tumors driven by Hippo pathway mutations.

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.