Pipeline
We measure ourselves by the impact we have on people with cancer.
Let’s go big.
| Preclinical | Phase 1 | Phase 2 | Phase 3 | Regulatory Submission | Approved | Collaborators |
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Nirogacestat (Gamma Secretase Inhibitor) |
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Approved in the U.S.
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Approved in the U.S. for the treatment of adult patients with progressing desmoid tumors who require systemic treatment.
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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.
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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.
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SpringWorks is evaluating nirogacestat as a potential treatment for patients with multiple myeloma as part of several B-cell maturation agent (BCMA) combination therapy regimens in collaboration with industry leaders.
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Mirdametinib (MEK Inhibitor) |
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Neurofibromatosis type 1-associated plexiform neurofibromas (NF1-PN) is a rare tumor of the peripheral nerve sheath that causes significant pain and disfigurement. A New Drug Application for mirdametinib, an investigational MEK inhibitor, for the treatment of adult and pediatric patients with NF1-PN is under review by the FDA. Mirdametinib has also received Orphan Drug, Fast Track and Rare Pediatric Disease designations for this indication.
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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.
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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.
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Brimarafenib (BGB-3245) (RAF Fusion and Dimer Inhibitor) |
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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.
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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.
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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.
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SW-682 (TEAD Inhibitor) |
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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.
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Nirogacestat (Gamma Secretase Inhibitor)
+ BCMA-Targeting Agents
Relapsed/refractory multiple myeloma
Phase 2 In Progress:
Collaborators:
Mirdametinib (MEK Inhibitor)
Monotherapy
Adult and pediatric NF1-associated plexiform neurofibromas
Phase 3 Complete:
+ Lifirafenib (RAF dimer inhibitor)
RAS/RAF mutant and other MAPK pathway aberrant solid tumors
Phase 1 In Progress:
Collaborators:
Brimarafenib (BGB-3245) (RAF Fusion and Dimer Inhibitor)
Monotherapy
MAPK mutant solid tumors
Phase 1 In Progress:
Collaborators:
+ Mirdametinib
MAPK mutant solid tumors
Phase 1 In Progress:
Collaborators:
1 Includes preclinical, Phase 1, and Phase 2 studies planned or ongoing with GSK, Janssen, Pfizer, Regeneron, and AbbVie. On June 6, 2024, GSK notified SpringWorks that it is terminating the collaboration agreement and winding down the study; no further enrollment is expected, though the study will continue for the patients enrolled at the time of termination notice.
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.