Gedatolisib Given FDA Priority Review and More Breast Cancer News

From FDA actions to new standard-of-care potential, the breast cancer treatment arsenal continues to expand. This week’s news in breast oncology features a priority review assignment in hormone receptor (HR)–positive, HER2-negative advanced breast cancer; new treatments for triple-negative breast cancer (TNBC); and an update to NCCN Clinical Practice Guidelines in Oncology for breast cancer.

Gedatolisib Granted Priority Review in HR+, HER2–, PIK3CA Wild-Type Advanced Breast Cancer

The FDA has accepted a new drug application (NDA) for gedatolisib, an investigational multi-targeted PI3K/AKT/mTOR (PAM) inhibitor, and granted it priority review for patients with HR-positive, HER2-negative, PIK3CA wild-type advanced breast cancer, according to a news release from Celcuity, the drug’s developer.¹ The action date for the FDA’s decision is set for July 17, 2026.

Gedatolisib is designed to induce a comprehensive blockade of the PAM pathway by targeting all four class I PI3K isoforms, mTORC1, and mTORC2. Its multi-target mechanism is intended to minimize the adaptive cross-activation often seen with single-target inhibitors. The submission is supported by clinical data from the phase 3 VIKTORIA-1 trial (NCT05501886), which is evaluating the drug in combination with fulvestrant (Faslodex) with or without palbociclib (Ibrance).

Sacituzumab Govitecan/Pembrolizumab Is Potential SOC for Advanced TNBC

Results from the phase 3 ASCENT-04/KEYNOTE-D19 trial (NCT05382286) published in the New England Journal of Medicine suggest that the combination of sacituzumab govitecan (Trodelvy) and pembrolizumab (Keytruda) may become a new standard of care (SOC) for the first-line treatment of PD-L1–positive, metastatic TNBC.^2,3

The combination reduced the risk of disease progression or death by 35% compared with standard-of-care chemotherapy plus pembrolizumab (HR, 0.65; 95% CI, 0.51-0.84; P <0.001), meeting the trial’s primary end point. Clinical data showed a median progression-free survival (PFS) of 11.2 months (95% CI, 9.3-16.7) for the combination arm vs 7.8 months (95% CI, 7.3-9.3) for the chemotherapy arm. Additionally, the objective response rate (ORR) was 60% (95% CI, 53%-66%) for the combination group compared with 53% (95% CI, 46%-60%) for the control group.

Median duration of response (DOR) was 16.5 months (95% CI, 12.7-19.5) and 9.2 months (95% CI, 7.6-11.3), respectively. Patients were randomly assigned 1:1 to intravenously receive sacituzumab govitecan at 10 mg/kg on days 1 and 8 and pembrolizumab at 200 mg on day 1 of a 21-day cycle or chemotherapy plus pembrolizumab.

Regarding safety, no new signals were identified, and the combination did not worsen the known safety profiles of either drug. Grade 3 or higher treatment-emergent adverse events (TEAEs) for the combination included neutropenia (43%) and diarrhea (10%); notably, fewer patients discontinued treatment due to TEAEs in the combination arm (12%) than in the chemotherapy arm (31%).

NCCN Guideline Update Reflects Breast Cancer Index Value

Updates to the NCCN Clinical Practice Guidelines in Oncology for breast cancer reinforce the Breast Cancer Index (BCI) Test as the only genomic assay predictive of benefit from extended endocrine therapy.⁴ The updated guidance supports the use of BCI for the prognostic assessment of late distant recurrence and for predicting extended endocrine therapy benefit in patients with HR-positive, HER2-negative disease. This recognition extends to both node-negative patients and those with 1 to 3 positive lymph nodes, with enhanced recognition of the test’s value specifically for the node-positive population.

Phase 1 Trial in the Works for TNBC Vaccine

The FDA has approved an investigational new drug (IND) application for a phase 1 trial of ITI-5000, a self-amplifying RNA cancer vaccine candidate, according to a news release from the drug’s developer, Immunomic Therapeutics.⁵ The study, titled VITALITI, will evaluate the vaccine with and without the addition of pembrolizumab in patients with stage II to III TNBC.

ITI-5000 uses a proprietary immunotherapy platform to deliver tumor antigens directly to lysosomes, where they are processed and presented to CD4-positive T cells to trigger a multi-layered immune response involving both B cells and CD8-positive T cells.⁶

The multicenter, open-label trial will compare assess safety, tolerability, and initial immune responses. Enrollment is planned to begin in the second quarter of 2026 across up to 8 medical institutions in the United States.

References

1. Celcuity announces FDA acceptance of new drug application for gedatolisib in HR+/HER2-/PIK3CA wild-type advanced breast cancer. News release. January 20, 2026. Accessed January 26, 2026.
2. Tolaney SM, de Azambuja E, Kalinsky K, et al. Sacituzumab govitecan plus pembrolizumab for advanced triple-negative breast cancer. N Engl J Med. 2026;394(4):354-366. doi:10.1056/NEJMoa2508959
3. New England Journal of Medicine publishes phase 3 ASCENT-04/KEYNOTE-D19 results supporting Trodelvy plus Keytruda as a potential new standard of care in first-line PD-L1+ metastatic triple-negative breast cancer. Gilead Sciences, Inc. News release. January 21, 2026. Accessed January 26, 2026. https://www.businesswire.com/news/home/20260120151830/en/New-England-Journal-of-Medicine-Publishes-Phase-3-ASCENT-04KEYNOTE-D19-Results-Supporting-Trodelvy-Plus-Keytruda-as-a-Potential-New-Standard-of-Care-in-First-line-PD-L1-Metastatic-Triple-negative-Breast-Cancer
4. NCCN. Clinical Practice Guidelines in Oncology. Breast cancer, version 1.2026. Accessed January 20, 2026. https://www.nccn.org/professionals/physician_gls/pdf/breast.pdf
5. Immunomic Therapeutics announces FDA clearance of IND application for a UNITE®-based self-amplifying RNA vaccine for triple-negative breast cancer, to be studied alone and in combination with Keytruda®. Immunomic Therapeutics, Inc. January 20, 2026. Accessed January 26, 2026. https://www.businesswire.com/news/home/20260120122000/en/Immunomic-Therapeutics-Announces-FDA-Clearance-of-IND-Application-for-a-UNITE-Based-Self-Amplifying-RNA-Vaccine-for-Triple-Negative-Breast-Cancer-to-Be-Studied-Alone-and-in-Combination-with-Keytruda
6. Park S. HLB unit wins FDA nod to start phase 1 RNA vaccine trial in breast cancer. ChosunBiz. January 19, 2026. Accessed January 26, 2026. https://biz.chosun.com/en/en-science/2026/01/19/II43VVNK4RH2HL7CFF5LA7OUY4/