1. FDA approves pembrolizumab for first-line treatment of head and neck ...
The Food and Drug Administration approved pembrolizumab (KEYTRUDA, Merck) for the first-line treatment of patients with metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC).
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2. Head and Neck Squamous Cell Cancer - Keytruda.com
KEYTRUDA is a prescription medicine used to treat a kind of cancer called head and neck squamous cell cancer (HNSCC). KEYTRUDA may be used with the chemotherapy ...
Learn about an immunotherapy treatment option that may help certain people fight head and neck squamous cell cancer at keytruda.com.
3. Pembrolizumab Confers Long-Term OS Benefit in Head and Neck ...
Oct 17, 2022 · Pembrolizumab, alone and in combination with chemotherapy, maintained an overall survival benefit compared with cetuximab plus chemotherapy for ...
Pembrolizumab, alone and in combination with chemotherapy, maintained an overall survival benefit compared with cetuximab plus chemotherapy for patients with recurrent or metastatic head and neck squamous cell carcinoma at 4 years.
4. Advanced head and neck squamous cell cancer - Keytruda.com
KEYTRUDA is a prescription medicine used to treat a kind of cancer called head and neck squamous cell cancer (HNSCC). KEYTRUDA may be used with the chemotherapy ...
Review the results from a clinical trial that included people who received KEYTRUDA® (pembrolizumab) for head and neck squamous cell cancer.
5. Pembrolizumab and cabozantinib in recurrent metastatic head and neck ...
Apr 3, 2023 · This phase 2 trial of pembrolizumab and cabozantinib in RMHNSCC revealed encouraging clinical activity in this disease and met its primary end ...
Anti-programmed cell death protein 1 (PD-1) therapy is a standard of care in recurrent metastatic head and neck squamous cell carcinoma (RMHNSCC). Vascular endothelial growth factor inhibitors, including tyrosine kinase inhibitors, have immunomodulatory properties and have offered promising results when combined with anti-PD-1 agents. We conducted a phase 2, multicenter, single-arm trial of pembrolizumab and cabozantinib in patients with RMHNSCC who had Response Evaluation Criteria in Solid Tumors v.1.1 measurable disease and no contraindications to either agent. We assessed the primary end points of tolerability and overall response rate to the combination with secondary end points of progression-free survival and overall survival and performed correlative studies with PDL-1 and combined positive score, CD8+ T cell infiltration and tumor mutational burden. A total of 50 patients were screened and 36 were enrolled with 33 evaluable for response. The primary end point was met, with 17 out of 33 patients having a partial response (52%) and 13 (39%) stable disease with an overall clinical benefit rate of 91%. Median and 1-year overall survival were 22.3 months (95% confidence interval (CI) = 11.7–32.9) and 68.4% (95% CI = 45.1%–83.5%), respectively. Median and 1-year progression-free survival were 14.6 months (95% CI = 8.2–19.6) and 54% (95% CI = 31.5%–72%), respectively. Grade 3 or higher treatment-related adverse events included increased aspartate aminotransferase (n = 2, 5.6%). In 16 patients (44.4%), the dose of cabozantinib was reduced to 20 mg daily. The overall response rate correlated positively with baseline CD8+ T cell infiltration. There was no observed correlation between tumor mutational burden and clinical outcome. Pembrolizumab and cabozantinib were well tolerated and showed promising clinical activity in patients with RMHNSCC. Further investigation of similar combinations are needed in RMHNSCC. The trial is registered at ClinicalTrials.gov under registration no. NCT03468218 . In a phase 2 trial of pembrolizumab and cabozantinib in patients with advanced head and neck cancer, a high clinical benefit rate was achieved, which positively correlated with levels of CD8+ T cell infiltration but not tumor mutational burden.
6. FDA Approves Pembrolizumab for Head and Neck Cancer - NCI
Aug 24, 2016 · The Food and Drug Administration (FDA) approved pembrolizumab (Keytruda®) on August 5 for the treatment of some patients with an advanced ...
FDA granted pembrolizumab accelerated approval for some patients with head and neck cancer.
7. Pembrolizumab in First-Line Treatment of Head/Neck Squamous ...
Sep 10, 2019 · In head and neck squamous cell carcinoma, the recommended dose of pembrolizumab is 200 mg administered as an intravenous infusion over 30 ...
By Matthew Stenger September 10, 2019
8. 5-year results from KEYNOTE-048 - ESMO Congress | OncologyPRO
Sep 10, 2022 · 659MO - Pembrolizumab with or without chemotherapy for first-line treatment of recurrent/metastatic (R/M) head and neck squamous cell carcinoma ...
OncologyPRO is the home of ESMO’s educational & scientific resources, with exclusive content for ESMO members such as ESMO’s Congresses webcasts,
9. A Study of Pembrolizumab in Combination With Chemotherapy ...
Jun 15, 2022 · A Study of Pembrolizumab in Combination With Chemotherapy for Head and Neck Cancer · Experimental: Group 1: Participants Who Receive ...
A Study of Pembrolizumab in Combination With Chemotherapy for Head and Neck Cancer - Full Text View.
10. Real-world treatment patterns and outcomes among individuals ...
Background: Pembrolizumab, a PD-1 immune checkpoint inhibitor, is approved as first-line (1L) treatment for recurrent or metastatic head and neck squamous cell ...
BackgroundPembrolizumab, a PD-1 immune checkpoint inhibitor, is approved as first-line (1L) treatment for recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) as monotherapy or in combination with platinum and 5-fluorouracil chemotherapy. Limited data exist on the use of these regimens in real-world settings.ObjectiveOur primary objectives were to describe baseline characteristics and real-world overall survival (rwOS), time on treatment (rwToT), and time to next treatment (rwTTNT) among individuals with R/M HNSCC receiving approved 1L pembrolizumab therapies. We also aimed to identify baseline factors associated with choice of 1L pembrolizumab therapy and with rwOS.MethodsThis was a retrospective cohort study of adults with R/M HNSCC receiving 1L pembrolizumab monotherapy or pembrolizumab plus chemotherapy. We used Kaplan-Meier analyses to assess real-world outcomes, logistic regression modeling to identify factors associated with choice of 1L pembrolizumab therapy, and Cox proportional hazards models to identify factors associated with rwOS.ResultsThe study population included 431 individuals receiving 1L pembrolizumab monotherapy and 215 receiving 1L pembrolizumab plus chemotherapy. The use of 1L pembrolizumab monotherapy was associated with higher baseline combined positive score for PD-L1 expression, older age, higher Eastern Cooperative Oncology Group performance status (ECOG PS), laryngeal tumor site, and human papillomavirus (HPV)-positive tumo...
11. A Phase III Study of Pembrolizumab Immunotherapy Before Surgery and ...
Pembrolizumab works by boosting the power of the immune system to find and kill cancer cells. Patients in this study will be randomly assigned to one of two ...
Full Title A Phase III, Randomized, Open-label Study to Evaluate Pembrolizumab as Neoadjuvant Therapy and in Combination With Standard of Care as Adjuvant Therapy for Stage III-IVA Resectable Locoregionally Advanced Head and Neck Squamous Cell Carcinoma (LA HNSCC) (WIRB) Purpose Radiation therapy with or without cisplatin chemotherapy is a standard treatment for squamous cell carcinoma of the head and neck.
12. Pembrolizumab given concomitantly with chemoradiation and as ...
Jun 3, 2020 · Current treatment guidelines for patients with locally advanced head and neck squamous cell carcinoma (HNSCC) recommend multimodal treatment ...
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13. Pembrolizumab +/- Chemotherapy Continues to Show OS Benefit in ...
Oct 18, 2022 · Pembrolizumab +/- Chemotherapy Continues to Show OS Benefit in HNSCC · Enfortumab Vedotin Elicits Compelling Data in Head and Neck Cancer · LEAP- ...
Long-term follow-up of KEYNOTE-048 shows improvements in overall survival with pembrolizumab monotherapy and in combination for patients with recurrent or metastatic head and neck squamous cell carcinoma.
14. [PDF] Pembrolizumab for Head and Neck Cancer - AIM with Immunotherapy
Pembrolizumab is indicated as monotherapy for the treatment of recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) that has progressed on ...
15. Pembrolizumab for untreated metastatic or unresectable recurrent ...
Nov 25, 2020 · Evidence-based recommendations on pembrolizumab (Keytruda) for untreated metastatic or unresectable recurrent head and neck squamous cell ...
Evidence-based recommendations on pembrolizumab (Keytruda) for untreated metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) in a
16. Pembrolizumab Plus Chemotherapy Demonstrates Continued Benefit in ...
Oct 21, 2022 · Findings from the phase 3 KEYNOTE-048 study indicated that long-lasting improved survival benefit can be achieved with pembrolizumab plus ...
Findings from the phase 3 KEYNOTE-048 study indicated that long-lasting improved survival benefit can be achieved with pembrolizumab plus chemotherapy compared with cetuximab and chemotherapy in patients with recurrent or metastatic head and neck squamous cell carcinoma.