October 2021: Cabozantinib (Cabometyx, Exelixis, Inc.) has been approved by the Food and Drug Administration for adult and paediatric patients 12 years of age and older who have locally advanced or metastatic differentiated thyroid cancer (DTC) that has progressed following prior VEGFR-targeted therapy and who are ineligible or refractory to radioactive iodine.
COSMIC-311, a randomised (2:1), double-blind, placebo-controlled, multicenter clinical trial (NCT03690388) in patients with locally advanced or metastatic DTC who had progressed after prior VEGFR-targeted therapy and were ineligible or refractory to radioactive iodine, was used to assess efficacy. Patients were given either cabozantinib 60 mg or placebo or best supportive care until disease progression or unacceptable toxicity.
The key effectiveness outcome measures were progression-free survival (PFS) in the intent-to-treat population and overall response rate (ORR) in the first 100 randomised patients, both of which were assessed by a blinded independent radiological review committee using the RECIST 1.1 criteria. Compared to placebo, CABOMETYX significantly reduced the risk of illness progression or death (p0.0001). The median PFS in the cabozantinib arm was 11.0 months (95 percent CI: 7.4, 13.8), compared to 1.9 months (95 percent CI: 1.9, 3.7) in the placebo arm. In the cabozantinib and placebo groups, the ORRs were 18 percent (95 percent CI: 10 percent, 29 percent) and 0 percent (95 percent CI: 0 percent, 11 percent), respectively.
Diarrhea, palmar-plantar erythrodysesthesia (PPE), weariness, hypertension, and stomatitis were the most prevalent adverse effects (25 percent). Hypocalcemia was inserted as a cautionary note.
Until disease progression or unacceptable toxicity, the recommended single-agent cabozantinib dose is 60 mg once daily. In paediatric patients (12 years of age and older with a BSA of less than 1.2 m2), the recommended cabozantinib dose is 40 mg once day until disease progression or intolerable toxicity.
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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.
