- |||||||||| Odomzo (sonidegib) / Sun Pharma, Libtayo (cemiplimab-rwlc) / Regeneron, Erivedge (vismodegib) / Roche
Review, Journal, Metastases: Immunotherapy and Its Timing in Advanced Basal Cell Carcinoma Treatment. (Pubmed Central) - Nov 22, 2023 In this review, we revisit the therapeutic decisions considering a switch from HHI to immunotherapy with anti-PD-1 agent cemiplimab and we highlight the place of cemiplimab in the therapeutic ladder for patients with advanced BCC. We discuss the evidence on the efficacy and safety of anti-PD-1 agents as second-line systemic monotherapy, or in combination with other treatments, and the emergence of checkpoint immunotherapy as a neoadjuvant treatment.
- |||||||||| Libtayo (cemiplimab-rwlc) / Regeneron, Keytruda (pembrolizumab) / Merck (MSD)
Review, Journal, Metastases: Advanced Cutaneous Squamous Cell Carcinoma Management in Immunotherapy Era: Achievements and New Challenges. (Pubmed Central) - Nov 22, 2023 Several questions related to the activity and the safety of immunotherapy in the real-world setting still remain without answer, and several points need to be better explored. In the current review we will explore the updated literature on the use of immunotherapy in cSCC, and we will show the current challenges in its use.
- |||||||||| Libtayo (cemiplimab-rwlc) / Regeneron
Enrollment change, Trial completion date, Trial primary completion date: Intralesional Cemiplimab for Adult Patients With Cutaneous Squamous Cell Carcinoma or Basal Cell Carcinoma (clinicaltrials.gov) - Nov 22, 2023 P1, N=109, Recruiting, In the current review we will explore the updated literature on the use of immunotherapy in cSCC, and we will show the current challenges in its use. N=61 --> 109 | Trial completion date: Jan 2024 --> Nov 2027 | Trial primary completion date: Oct 2023 --> Sep 2027
- |||||||||| Review, Journal, Checkpoint inhibition, Metastases: Treatment of locally advanced and metastatic basosquamous carcinoma, navigating among sonic hedgehog pathway inhibitors, immune checkpoint inhibitors, chemotherapy, and radiotherapy: A case series and literature review. (Pubmed Central) - Nov 6, 2023
According to these preliminary data, HHIs such as sonidegib and vismodegib could represent a safe and effective first line of treatment, while the anti-PD-1 cemiplimab may be useful as a second-line option. Chemotherapy and combined approaches involving surgery and radiotherapy have been also reported to be suitable in some patients.
- |||||||||| Journal, Adverse events, Checkpoint inhibition: Survival Among Veterans Receiving Steroids for Immune-Related Adverse Events After Immune Checkpoint Inhibitor Therapy. (Pubmed Central) - Nov 4, 2023
Eligible patients in the steroid group received at least 1 dose (intravenous, intramuscular, or oral) of dexamethasone, hydrocortisone, methylprednisolone, prednisone, or prednisolone...This study suggests that steroids for irAE management may not abrogate irAE-associated survival benefits. However, early steroid administration within 2 months of ICI initiation is associated with shorter survival despite continuation of ICI therapy.
- |||||||||| Libtayo (cemiplimab-rwlc) / Regeneron
Enrollment closed: CASE: CemiplimAb Survivorship Epidemiology (clinicaltrials.gov) - Oct 30, 2023 P=N/A, N=287, Active, not recruiting, Trial primary completion date: Dec 2023 --> Dec 2024 Recruiting --> Active, not recruiting
- |||||||||| BNT112 / BioNTech
Enrollment closed, Enrollment change, Trial completion date, Trial primary completion date, Monotherapy: PRO-MERIT (Prostate Cancer Messenger RNA Immunotherapy) (clinicaltrials.gov) - Oct 25, 2023 P1/2, N=75, Active, not recruiting, Baseline tumor load (i.e., MTV and TLG) and metabolic response at 12 weeks may have a prognostic impact in cSCC patients treated with cemiplimab. Recruiting --> Active, not recruiting | N=115 --> 75 | Trial completion date: Jul 2023 --> Oct 2024 | Trial primary completion date: Jul 2023 --> Jan 2024
- |||||||||| Libtayo (cemiplimab-rwlc) / Regeneron
Enrollment change: CASE: CemiplimAb Survivorship Epidemiology (clinicaltrials.gov) - Oct 1, 2023 P=N/A, N=300, Recruiting, Recruiting --> Active, not recruiting N=500 --> 300
- |||||||||| Libtayo (cemiplimab-rwlc) / Regeneron
Infliximab for decompensated diabetes following immune checkpoint inhibitor therapy (Exhibit Hall B) - Sep 27, 2023 - Abstract #SITC2023SITC_1569; Results A 71-year-old man with metastatic squamous cell carcinoma of the jaw and a history of diet-controlled diabetes acutely developed weight loss, polyuria, and polydipsia with a rise of his serum glucose to 398 mg/dL following a 9th dose of cemiplimab, an anti PD-1 monoclonal antibody...At seven months of follow-up, he continued on metformin and dulaglutide with a hemoglobin A1C of 5...If true, this would save patients substantial morbidity. We believe this preliminary data warrants further study including randomized controlled trials.
- |||||||||| Safety of Immune checkpoint inhibitors in elderly patients over 75 years (Exhibit Hall B) - Sep 27, 2023 - Abstract #SITC2023SITC_1533;
Conclusions Our study demonstrates that elderly patients with cancer who receive ICI treatment are not at increased risk of irAE compared to younger patients. These findings suggest that age alone should not preclude older adults from receiving ICI therapy, and that these treatments can be safely and effectively used in older adults.
- |||||||||| Safety of immune checkpoint inhibitors in cancer patients with HIV (Exhibit Hall B) - Sep 27, 2023 - Abstract #SITC2023SITC_809;
Conclusions Our study demonstrates that HIV patients who receive ICI treatment have similar risk of irAE compared to non-HIV patients, indicating that ICI treatment is safe in this population. Eligibility criteria for clinical trials should be expanded to include HIV patients to improve health outcomes in this population.
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