Pembrolizumab & HNSCC: Improved Cure Rates
- The Food and Drug Management has given the green light to pembrolizumab (Keytruda) as a treatment before and after surgery for resectable, locally advanced head and neck squamous...
- Specifically, the FDA approved the drug for HNSCC tumors expressing PD-L1.The regimen involves pembrolizumab as a single agent before surgery, followed by radiation with or without cisplatin after...
- The FDA noted this is the first approval in six years for HNSCC and another for perioperative immunotherapy cancer treatment.Some oncologists have expressed concern over the design of...
FDA OKs Pembrolizumab Regimen for Head and Neck Cancer
The Food and Drug Management has given the green light to pembrolizumab (Keytruda) as a treatment before and after surgery for resectable, locally advanced head and neck squamous cell carcinoma (HNSCC). this approval marks a notable advancement in cancer treatment, offering a new standard of care for certain patients.
Specifically, the FDA approved the drug for HNSCC tumors expressing PD-L1.The regimen involves pembrolizumab as a single agent before surgery, followed by radiation with or without cisplatin after the operation. Maintenance therapy with pembrolizumab continues after that.
The FDA noted this is the first approval in six years for HNSCC and another for perioperative immunotherapy cancer treatment.Some oncologists have expressed concern over the design of company trials, which often lack arms to determine if immunotherapy is necessary both before and after surgery.
Dr. Barbara Burtness, a head and neck oncologist at Yale University, saeid she plans to offer the new pembrolizumab regimen to eligible patients. She cited the strength of the KEYNOTE-689 trial, which supported the approval, as a key factor, emphasizing the potential for a cure when tumors are resectable. This new role for pembrolizumab could substantially impact treatment strategies.
“Many of us think it’s the new standard of care,” Burtness said.
The KEYNOTE-689 trial,a multicenter,open-label study,involved 682 patients with resectable stage III-IVa disease whose tumors had a PD-L1 combined positive score of at least 1. The study compared the standard of care (surgery followed by radiotherapy with or without cisplatin) to a pembrolizumab add-on regimen. The pembrolizumab group received the drug every three weeks for two cycles before surgery, then for three cycles afterward with radiotherapy and possible cisplatin, followed by 12 cycles of pembrolizumab maintenance.
Cisplatin was administered post-surgery to patients at high risk of recurrence, such as those with incomplete tumor removal or spread beyond their lymph nodes. The role of cisplatin is crucial in these high-risk cases.
The trial demonstrated a median event-free survival of 59.7 months with pembrolizumab compared to 29.6 months without it. While overall survival data was not yet mature, there was no decrease observed with the pembrolizumab add-on. The roles of different therapies are being redefined.
No new safety concerns emerged during the trial. However, pembrolizumab labeling includes warnings about immune-mediated adverse events, infusion-related reactions, and embryo-fetal toxicity. In KEYNOTE-689, 1.4% of pembrolizumab recipients were unable to undergo surgery due to side effects.
The FDA advises that pembrolizumab should be administered before chemotherapy when both are given on the same day.