The FDA grants KEYTRUDA® (pembrolizumab) accelerated approval for the treatment of R/R cHL

On the 14th March 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval to KEYTRUDA® (pembrolizumab) for the treatment of pediatric and adult patients with classical Hodgkin Lymphoma (cHL) who are refractory or who have relapsed after ≥ 3 prior lines of treatment.1

This accelerated approval for pembrolizumab, a monoclonal anti-PD-1 IgG4 antibody, is based on the phase 2 KEYNOTE-087 (NCT02453594) trial, which investigated pembrolizumab treatment in patients with R/R cHL.

Key Highlights of KEYNOTE-087:1
  • Pts enrolled = 210; Median age = 35yrs (range, 18–76yrs); Median follow-up = 9.4 months
  • Pembrolizumab administered at 200mg every 3 weeks in until PD, unacceptable toxicity, or up to 2yrs in pts who did not experience progression
  • ORR = 69% (95% CI, 62–75%); CR = 22%; PR = 47%
  • Median DoR in responding pts (n=145) = 11.1 months (range, 0+ to 11.1)
  • Most frequent AEs = fatigue (26%), pyrexia and cough (24% each), musculoskeletal pain (21%), and diarrhea and rash (20% each)
  • SAEs reported in 16% pts; the most common SAEs incl. pneumonia, pneumonitis, pyrexia, dyspnea, GVHD, and herpes zoster
  • AEs leading to discontinuations in 5% pts; AEs leading to treatment interruptions in 26% pts
  • Two deaths reported, both unrelated to disease: septic shock (n=1) and GvHD after subsequent allo-HSCT (n=1)

For safety data, 40 pediatric patients with PD-L1-positive, advanced, R/R solid tumors, advanced melanoma, or lymphoma were assessed by the FDA. The safety profile was consistent with that reported in adults. Some AEs were observed at a higher rate (≥15% difference) in pediatric patients, such as fatigue, vomiting, abdominal pain, hypertransaminasemia, and hyponatremia.

The approved regimens of pembrolizumab are 200mg every 3 weeks for adults and 2mg/kg (up to 200mg) every 3 weeks for pediatric patients. This is the first FDA indication for pembrolizumab in a hematologic malignancy.

To date, pembrolizumab has FDA approvals in:2

  • Patients with unresectable or metastatic melanoma
  • Patients with metastatic NSCLC whose tumors have high PD-L1 expression [(Tumor Proportion Score (TPS) ≥50%)] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, and no prior systemic chemotherapy treatment for metastatic NSCLC
  • Patients with metastatic NSCLC whose tumors express PD-L1 (TPS ≥1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy
    • Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA®
  • Patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy
    • This indication is approved under accelerated approval based on tumor response rate and durability of response
  1. FDA Approves Pembrolizumab for Hodgkin Lymphoma. 2017 Mar 14. http://www.onclive.com/web-exclusives/fda-approves-pembrolizumab-for-hodgkin-lymphoma. [Accessed 2017 Mar 15].
  2. KEYTRUDA® Prescribing Information. 2017 Mar. http://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_pi.pdf. [Accessed 2017 Mar 15].
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