Glenn J. Hanna, MD, is the director of the Center for Cancer Therapeutic Innovation (Early Drug Development Program) and director of the Center for Salivary and Rare Head and Neck Cancers at Dana-Farber Cancer Institute; as well as an associate professor of medicine at Harvard Medical School

Dr Hanna on Elraglusib Plus Chemotherapy and Immunotherapy in Advanced Salivary Gland Cancer

“When you start to look at a couple of key subgroups, like those patients who had non-adenoid cystic–type salivary [gland] cancer and those who had a little bit of higher expression of GSK 3β staining, there was actually a higher response rate.”

Glenn J. Hanna, MD, director of the Center for Cancer Therapeutic Innovation (Early Drug Development Program) and director of the Center for Salivary and Rare Head and Neck Cancers at Dana-Farber Cancer Institute; as well as an associate professor of medicine at Harvard Medical School, discussed efficacy outcomes from a phase 2 trial (NCT05010629) investigating the GSK 3β inhibitor elraglusib (9-ING-41) plus chemotherapy with or without immunotherapy in patients with advanced salivary gland cancer.

This single-arm, single-center, open-label trial enrolled patients with any primary site of salivary gland cancer. Patients needed to have recurrent or metastatic, incurable disease and could have received any number of prior systemic therapies. They also needed to have measurable disease per RECIST 1.1 criteria with progression in the preceding 12 months, an ECOG performance status of 0 or 1, and adequate bone marrow and organ function.

In part 1, patients received intravenous (IV) elraglusib at 15 mg/kg on days 1 and 4 plus IV carboplatin at an area under the curve of 5 on day 1 of 21-day cycles. In part 2, patients received IV pembrolizumab (Keytruda) at 200 mg on day 1 of cycles 1 and 2, followed by the same elraglusib/carboplatin regimen used in part 1 in cycles 3 and beyond.

In the full population (n = 32), the primary end point of best overall response rate (ORR) per RECIST 1.1 criteria was not met. The ORR in this population was 9.4% (95% CI, 2%-25%). However, among the key subgroup of patients with non-adenoid cystic disease—which was associated with higher nuclear expression of GSK 3β—the ORR was 18%, he said. This outcome is exciting, as an ORR of approximately 20% is typically a signal that a drug or combination regimen might have antitumor activity, he explained.

Videos

Glenn J. Hanna, MD, discusses the efficacy of elraglusib plus chemotherapy with or without immunotherapy in patients with advanced salivary gland cancer.

Glenn J. Hanna, MD, director, Center for Cancer Therapeutic Innovation (Early Drug Development Program), director, Center for Salivary and Rare Head and Neck Cancers, physician, Dana-Farber Cancer Institute; assistant professor, medicine, Harvard Medical School, discusses the significance of the FDA approval of toripalimab-tpzi (Loqtorzi) for patients with recurrent or metastatic nasopharyngeal carcinoma.

the FDA approved the combination of toripalimab, cisplatin, and gemcitabine

for the treatment of adult patients with metastatic or locally recurrent nasopharyngeal carcinoma that has progressed on or after platinum-containing chemotherapy, irrespective of PD-L1 status. The agent also gained approval as a monotherapy for adults with recurrent, unresectable, or metastatic nasopharyngeal carcinoma that has progressed on or after treatment with platinum-based chemotherapy. 

This regulatory decision was backed by findings from the phase 3 JUPITER-02 (NCT03581786) and phase 2 POLARIS-02 (NCT02915432) trials. In JUPITER-02, the combination led to a 48% reduction in the risk of disease progression or death vs chemotherapy alone (HR = 0.52; 95% CI, 0.36-0.74; 

 < .0003), as well as a 37% reduction in the risk of death compared with chemotherapy alone. In POLARIS-02, toripalimab generated an overall response rate of 20.5%, a disease control rate of 40.0%, and a median overall survival of 17.4 months.

Viral-associated nasopharyngeal carcinoma, including Epstein-Barr virus (EBV)–associated disease, is not as common in Western countries as it is in Asia and northern Africa. This is likely because of the epidemiology of the EBV virus, Hanna says. Prior to this approval, little data existed to guide treatment decisions for patients with nasopharyngeal carcinoma in the United States, as most clinical trials in this population were conducted in Asia, Hanna explains.

The JUPITER-02 regimen combined toripalimab, an immunotherapy agent, with the standard gemcitabine/cisplatin backbone for patients with advanced disease, Hanna notes. This combination improves responses, survival outcomes, and time to progression in this patient population, Hanna emphasizes. Chemoimmunotherapy regimens have proven effective in other cancer types, such as head and neck squamous cell carcinomas excluding nasopharyngeal carcinoma, according to Hanna. This FDA approval demonstrates the benefits of such combinations in patients with this unique subtype of head and neck cancer, Hanna concludes.

Glenn J. Hanna, MD, discusses the significance of the FDA approval of toripalimab for patients with recurrent or metastatic nasopharyngeal carcinoma.

Glenn J. Hanna, MD

Articles

Dr Hanna on Elraglusib Plus Chemotherapy and Immunotherapy in Advanced Salivary Gland Cancer

Dr Hanna on the FDA Approval of Toripalimab in Nasopharyngeal Carcinoma