Pembrolizumab is approved for adjuvant treatment of renal cell carcinoma

Jan 2022: Pembrolizumab (Keytruda, Merck) has been approved by the Food and Drug Administration for the adjuvant treatment of patients with renal cell carcinoma (RCC) who are at intermediate-high or high risk of recurrence after nephrectomy, or after nephrectomy plus resection of metastatic lesions.

Efficacy was assessed in 994 patients with intermediate-high or high risk of recurrence of RCC, or M1 no evidence of illness, in KEYNOTE-564 (NCT03142334), a multicenter, randomised (1:1), double-blind, placebo-controlled trial. Patients were given either pembrolizumab 200 mg intravenously every 3 weeks or placebo for up to a year, or until illness recurrence or intolerable toxicity, whichever came first.

Disease-free survival (DFS), defined as the period between recurrence, metastasis, or death, was the primary effectiveness outcome measure. Overall survival was another outcome metric (OS). A prespecified interim analysis revealed a statistically significant improvement in DFS, with 109 (22%) occurrences in the pembrolizumab arm and 151 (30%) events in the placebo arm (HR 0.68; 95 percent CI: 0.53, 0.87; p=0.0010). In neither arm, the median DFS was reached. OS data were not complete at the time of the DFS analysis, with 5% of the population dying.

Musculoskeletal discomfort, weariness, rash, diarrhoea, pruritus, and hypothyroidism were the most common adverse effects in this experiment (20 percent).

Pembrolizumab is given in doses of 200 mg every three weeks or 400 mg every six weeks until illness recurrence, intolerable toxicity, or up to 12 months.

Click here for full prescribing information for Keytruda.

Nishant Mittal (PhD)

+ postsBio ⮌

Dr. Nishant Mittal is a highly accomplished researcher with over 13 years of experience in the fields of cardiovascular biology and cancer research. His career is marked by significant contributions to stem cell biology, developmental biology, and innovative research techniques.

Research Highlights

Dr. Mittal's research has focused on several key areas:

1) Cardiovascular Development and Regeneration: He studied coronary vessel development and regeneration using zebrafish models1.

2) Cancer Biology: At Dartmouth College, he developed zebrafish models for studying tumor heterogeneity and clonal evolution in pancreatic cancer.
3) Developmental Biology: His doctoral work at Keio University involved identifying and characterizing medaka fish mutants with cardiovascular defects.

4) Stem Cell Research: He investigated the effects of folic acid on mouse embryonic stem cells and worked on cryopreservation techniques for hematopoietic stem cells.

Publications and Presentations

Dr. Mittal has authored several peer-reviewed publications in reputable journals such as Scientific Reports, Cardiovascular Research, and Disease Models & Mechanisms1. He has also presented his research at numerous international conferences, including the Stanford-Weill Cornell Cardiovascular Research Symposium and the Weinstein Cardiovascular Development Conference.

In summary, Dr. Nishant Mittal is a dedicated and accomplished researcher with a strong track record in cardiovascular and cancer biology, demonstrating expertise in various model systems and a commitment to advancing scientific knowledge through innovative research approaches.

• Nishant Mittal (PhD)

  https://cancerfax.com/author/nishantm/

  Brentuximab vedotin with lenalidomide and rituximab is approved by the USFDA for relapsed or refractory large B-cell lymphoma
• Nishant Mittal (PhD)

  https://cancerfax.com/author/nishantm/

  Mirdametinib is approved by the USFDA for adult and pediatric patients with neurofibromatosis type 1 who have symptomatic plexiform neurofibromas not amenable to complete resection
• Nishant Mittal (PhD)

  https://cancerfax.com/author/nishantm/

  Datopotamab deruxtecan-dlnk is approved by the USFDA for unresectable or metastatic, HR-positive, HER2-negative breast cancer
• Nishant Mittal (PhD)

  https://cancerfax.com/author/nishantm/

  Remestemcel-L-rknd is approved by the USFDA for steroid-refractory acute graft versus host disease in pediatric patients