On December 13, 2024, the Food and Drug Administration sanctioned cosibelimab-ipdl (Unloxcyt, Checkpoint Therapeutics, Inc.), a programmed death ligand-1 (PD-L1) inhibiting antibody, for adults with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced cutaneous squamous cell carcinoma (laCSCC) who are ineligible for curative surgery or radiation therapy.
Effectiveness and Safety
The efficacy was assessed in Study CK-301-101 (NCT03212404), a multicenter, multicohort, open-label trial involving 109 patients with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced cutaneous squamous cell carcinoma (laCSCC) who were ineligible for curative surgery or radiation.
Patients were excluded if they had any of the following conditions: active or suspected autoimmune disease, allogeneic transplant within six months prior to treatment, previous treatment with anti-PD-1/PD-L1 blocking antibodies or other immune checkpoint inhibitors, uncontrolled or significant cardiovascular disease, ECOG performance status ≥ 2, or infection with HIV, hepatitis B, or hepatitis C.
The primary efficacy outcome measures were objective response rate (ORR) and duration of response (DOR), evaluated by an independent central review committee (IRC) in accordance with RECIST version 1.1. In patients with laCSCC exhibiting externally visible target lesions that cannot be evaluated using radiologic imaging, the overall response rate (ORR) was ascertained via independent central review (ICR) of digital photography according to WHO guidelines. ORR was 47% (95% CI: 36, 59) for patients with mCSCC (n=78) and 48% (95% CI: 30, 67) for patients with laCSCC (n=31).
The median duration of response (DOR) was not attained (range: 1.4+, 34.1+) in patients with metastatic cutaneous squamous cell carcinoma (mCSCC) and was 17.7 months (range: 3.7+, 17.7) in patients with locally advanced cutaneous squamous cell carcinoma (laCSCC).
Negative Responses
The predominant adverse responses (≥10%) included fatigue, musculoskeletal pain, rash, diarrhea, hypothyroidism, constipation, nausea, headache, pruritus, edema, localized infection, and urinary tract infection.
The advised dosage of cosibelimab-ipilimumab is 1,200 mg, delivered via intravenous infusion for a duration of 60 minutes every three weeks, continuing until disease progression or intolerable toxicity occurs.
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.
