Neoadjuvant/ adjuvant pembrolizumab is approved by the FDA for resectable non-small cell lung cancer

Neoadjuvant/ adjuvant pembrolizumab is approved by the FDA for resectable non-small cell lung cancer
The Food and Drug Administration approved pembrolizumab (Keytruda, Merck) with platinum-containing chemotherapy as neoadjuvant treatment, and with continuation of single-agent pembrolizumab as post-surgical adjuvant treatment for resectable (tumors ≥4 cm or node positive) non-small cell lung cancer (NSCLC).

Share This Post

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 (NCT03425643), a multicenter, randomised, 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 randomised (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).

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. Moreover, surgical delays caused by adverse reactions were observed in 3.1% of patients who received neoadjuvant treatment and surgery in the pembrolizumab arm, 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.

View full prescribing information for Keytruda.

Subscribe To Our Newsletter

Get updates and never miss a blog from Cancerfax

More To Explore

Need help? Our team is ready to assist you.

We wish a speedy recovery of your dear and near one.

درمان سرطان در تركيه
Start chat
Need help with cancer treatment?
Scan the code
Welcome to CancerFax !

CancerFax is the most trusted international patient facilitator working with top cancer hospital's in the world like MD Anderson, Dana Farber, Asan, NCC Japan, Sheba, Beijing Cancer Institute and Apollo to bring you best of therapies and drugs.

Let us know what services would you like to avail?

1) Cancer treatment in the USA, Japan, Israel, India, Korea or Singapore?
2) CAR T-Cell therapy treatment
3) Cancer vaccine
4) Online video consultation
5) Proton therapy