Cemiplimab

Incidence of squamous cell anal carcinoma (SCAC) is rising; ASCO's 2024 guideline recommends concurrent chemoradiation with mitomycin-C and 5-fluorouracil or capecitabine. Retifanlimab, a checkpoint inhibitor, showed improved progression-free survival and overall survival in phase 3 trials, potentially becoming a new standard of care for SCAC. SCAC, primarily HPV-driven, remains a significant unmet medical need with no FDA-approved treatments for advanced disease.

DelveInsight's report on PD-1 Non-Small Cell Lung Cancer Market (2020-2034) highlights market growth, approvals, prevalence, therapies, and companies like Merck, Bristol-Myers Squibb, Genentech, and others. Key therapies include KEYTRUDA, OPDIVO, TECENTRIQ, and TIZVENI. Market drivers include premium-priced targeted agents and therapy expansion, while barriers include premium pricing of emerging therapies.

NCCN guidelines now recommend osimertinib for unresectable NSCLC with EGFR mutations and durvalumab for LS-SCLC, reflecting significant PFS and OS benefits from ADRIATIC and LAURA studies. These updates influence treatment discussions with patients, emphasizing upfront molecular testing and potential systemic therapy post-chemoradiation.

CancerNetwork panel discussed immunotherapy efficacy in NSCLC, focusing on combination therapies and dual vs. single-agent measures. A clinical scenario involving a KRAS G12D, STK11-positive, PD-L1-negative adenocarcinoma patient highlighted the debate on ideal treatment, with consensus leaning towards chemoimmunotherapy. The panel also explored the potential of AXL inhibitors to overcome STK11 mutations, with ongoing trials examining their use alongside immunotherapy.

Cemiplimab-rwlc is indicated for locally advanced BCC previously treated with a hedgehog pathway inhibitor (HHI) or for whom HHI is not appropriate, or metastatic BCC (mBCC) previously treated with HHI or for whom HHI is not appropriate. The approval for mBCC is based on tumor response rates and durability of response noted in a trial. Medical oncologists often continue treatment initiated by dermatology, especially due to progression. Patient-specific factors leading to HHI inappropriateness include cachexia, peripheral vascular disease, and patient refusal due to alopecia. HHIs are typically continued for 8-12 weeks, with discontinuation if no response or intolerable toxicity. Cemiplimab was investigated in a phase 2 study, showing an overall response rate of 22% by independent central review, with a median progression-free survival of 10 months and a 12-month overall survival rate of 83%. Treatment-emergent adverse events (AEs) with cemiplimab include fatigue, GI AEs, and hypertension. HHIs are often discontinued due to AEs like muscle spasms, arthralgias, fatigue, taste changes, and weight loss, which may persist for weeks to months after discontinuation.

Biomarker testing crucial in metastatic NSCLC, guiding precision medicine and treatment decisions. Actionable biomarkers like EGFR, ALK, and PD-L1 inform therapy. Immunotherapy, particularly ICIs, is a key treatment option, though PD-L1 has limitations. Emerging biomarkers like STK11, KEAP1, and SMARCA4 are under investigation to refine patient selection for immunotherapy.