In this article
FDA Approval of Pembrolizumab for Resectable NSCLC
Nov 2023: Pembrolizumab (Keytruda, Merck) was granted approval by the Food and Drug Administration (FDA) as a neoadjuvant treatment in combination with platinum-containing chemotherapy and as a post-surgical adjuvant treatment for resectable non-small cell lung cancer (NSCLC) tumours measuring 4 cm or more in diameter, when combined with platinum-containing chemotherapy.
KEYNOTE-671 Clinical Trial Overview and Efficacy Results
KEYNOTE-671 (NCT03425643), a multicenter, randomized, double-blind, placebo-controlled trial involving 797 patients with AJCC 8th edition resectable Stage II, IIIA, or IIIB NSCLC who had not been previously treated, assessed the drug’s efficacy. Patients undergoing platinum-based chemotherapy were randomized (1:1) to receive pembrolizumab or a placebo every three weeks for four cycles (neoadjuvant treatment).
Subsequently, for a maximum of thirteen cycles (adjuvant treatment), patients were administered either continued single-agent pembrolizumab or a placebo every three weeks. The surgical window and chemotherapy specifics are available at the link to the drug label above.
The primary outcome measures of efficacy were investigator-assessed event-free survival (EFS) and overall survival (OS). The median OS for those receiving placebo was 52.4 months (95% CI: 45.7, NE) and was not attained in the pembrolizumab arm (95% CI: not estimable [NE], NE]; p-value=0.0103). The risk ratio [HR] was 0.72 [95% CI: 0.56, 0.93]; p-value=0.0103]. The median EFS in the placebo arm was 17 months (95% CI: 14.3, 22.0) compared to 17 months in the pembrolizumab arm (95% CI: 34.1 months, NE) (HR 0.58 [95% CI: 0.46, 0.72]; p-value=0.0001).
Safety Profile and Dosage Administration for Pembrolizumab
The adverse reactions most frequently reported by 20% or more of the patients in KEYNOTE-671 were as follows: nausea, fatigue, neutropenia, anaemia, constipation, decreased appetite, decreased white blood cell count, musculoskeletal pain, rash, congestion, vomiting, diarrhoea, and dyspnea.
A comparatively lower rate of adverse reactions prevented surgery for 6% of patients in the pembrolizumab arm who received neoadjuvant treatment, as opposed to 4.3% in the placebo arm. In addition, 3.1% of patients who received neoadjuvant treatment and surgery in the pembrolizumab arm experienced surgical delays as compared to 2.5% in the placebo arm. The safety information pertaining to the neoadjuvant and adjuvant phases can be found in the drug label link provided above.
Pembrolizumab is prescribed at a dosage of 200 mg every 3 weeks or 400 mg every 6 weeks. When administered on the same day as chemotherapy, pembrolizumab should be administered beforehand.
How CancerFax Helps
CancerFax is a specialist cancer access and patient-navigation platform. We help patients and families understand their options, organise medical records, coordinate hospital communication, and support cross-border treatment planning where appropriate.
We help collect and organise reports, scans, pathology, biomarker results, and treatment history for structured case review.
We communicate with hospitals or trial teams to assess whether a case may be suitable for further screening.
We support appointment coordination, document submission, translation, and direct communication with international departments.
For international patients, we help with practical coordination — travel planning, hospital admission guidance, and local support.
If this option is not suitable, we help explore other relevant treatments, clinical trials, or advanced care pathways.
From inquiry through to follow-up, our coordinators provide a single point of contact for the family.
CancerFax does not guarantee treatment access, eligibility, or clinical outcome. Our role is to help patients access accurate information, structured review, and appropriate specialist pathways.
About Dr. Nishant Mittal
Dr. Nishant Mittal is a highly accomplished researcher with over 13 years of experience in the fields of cardiovascular biology and cancer research. Significant contributions to stem cell biology, developmental biology, and innovative research techniques mark his career. Research Highlights Dr. Mittal's research has focused on several key areas: 1) Cardio…
✓ Reviewed for medical accuracy by the CancerFax review panel.
Medical Disclaimer
This article is for educational purposes only and should not replace medical advice, diagnosis, or treatment from a qualified oncology specialist. Every patient's case is different. Treatment decisions should always be made after a review of complete medical records by the treating medical team.
Treatment availability, eligibility, timelines, and access can change. Any clinical trial participation depends on detailed review and approval by the trial hospital or investigator.