- |||||||||| Libtayo (cemiplimab) / Regeneron, Keytruda (pembrolizumab) / Merck (MSD), Opdivo (nivolumab) / Ono Pharma, BMS
Review, Journal, Tumor Mutational Burden, PD(L)-1 Biomarker, IO biomarker: Immunotherapy for the Treatment of Squamous Cell Carcinoma: Potential Benefits and Challenges. (Pubmed Central) - Aug 22, 2022 Despite the high tolerability and efficiency, the existence of some challenges has been revealed such as, resistance to immunotherapy, less availability of the biomarkers, and difficulty in appropriate patient selection. This review aims to accumulate evidence regarding the genetic alterations related to SCC, the factors that contribute to the potential benefits of immunotherapy, and the challenges to follow this treatment regime.
- |||||||||| Odomzo (sonidegib) / Sun Pharma, Libtayo (cemiplimab) / Regeneron, Erivedge (vismodegib) / Roche
Review, Journal: Systemic Targeted Treatments for Basal Cell Carcinoma. (Pubmed Central) - Aug 22, 2022 The sonic hedgehog (SHH) inhibitors vismodegib and sonidegib are the only 2 first-line systemic medications approved for the treatment of locally aggressive basal cell carcinoma (BCC)...Cemiplimab, an immune checkpoint inhibitor (ICI), is now an approved second-line therapy for locally advanced or metastatic BCC...Given the high rate of recurrence and emerging concern regarding drug resistance, maintenance dosing regimens and potential synergism with other treatment modalities, such as radiotherapy or antifungal therapy, should be further explored. The use of SHH inhibitors in the neoadjuvant setting also is warranted, as it may allow for surgical management of previously inoperable cases of BCC.
- |||||||||| Odomzo (sonidegib) / Sun Pharma, Libtayo (cemiplimab) / Regeneron, Erivedge (vismodegib) / Roche
Review, Journal: Advances in Management and Therapeutics of Cutaneous Basal Cell Carcinoma. (Pubmed Central) - Aug 14, 2022 Small and low-risk BCCs, broad field cancerization, locally-advanced disease, metastatic disease, cosmetic concerns, or morbidity with surgical approaches raise consideration of other treatment modalities. We review herein a range of treatment approaches and advances in treatments for BCC, including standard excision, MMS, electrodesiccation and curettage, ablative laser treatment, radiation therapy, targeted molecular therapies, topical therapies, field therapies, immunotherapy, and experimental therapies.
- |||||||||| SAR441000 / Sanofi, BioNTech
Enrollment change, Monotherapy: A First-in-Human Dose Escalation and Expansion Study to Evaluate Intratumoral Administration of SAR441000 as Monotherapy and in Combination With Cemiplimab in Patients With Advanced Solid Tumors (clinicaltrials.gov) - Aug 12, 2022 P1, N=77, Active, not recruiting, We review herein a range of treatment approaches and advances in treatments for BCC, including standard excision, MMS, electrodesiccation and curettage, ablative laser treatment, radiation therapy, targeted molecular therapies, topical therapies, field therapies, immunotherapy, and experimental therapies. N=231 --> 77
- |||||||||| Review, Journal, Checkpoint inhibition, PD(L)-1 Biomarker, IO biomarker: Immune checkpoint blockades in gynecological cancers: A review of clinical trials. (Pubmed Central) - Aug 7, 2022
As revealed in phase III trials, pembrolizumab (a PD-1 antibody) improved the overall survival and progression-free survival in endometrial cancer patients with mismatch repair deficiency and cervical cancer patients with expressions of PD-L1...Other PD-1 antibodies, including dostarlimab and cemiplimab, also showed antitumor efficacy in clinical trials...Three completed phase III trials investigated anti-PD-L1 agents (atezolizumab and avelumab) in the treatment of ovarian cancer...Other strategies of ICB therapy which had showed potential clinical benefit in the treatment of gynecological cancers in early-phase trials need to be further evaluated in late-stage trials. The antitumor efficacy of ICB therapy is promising, and the key to making further progress in the treatment of gynecological cancers is to identify more biomarkers and explore innovative combination treatments with other targeted therapies.
- |||||||||| Pexa-Vec (pexastimogene devacirepvec) / SillaJen
Enrollment closed: JX594-REN026: A Study of Recombinant Vaccinia Virus in Combination With Cemiplimab for Renal Cell Carcinoma (clinicaltrials.gov) - Aug 5, 2022 P1b/2a, N=89, Active, not recruiting, The antitumor efficacy of ICB therapy is promising, and the key to making further progress in the treatment of gynecological cancers is to identify more biomarkers and explore innovative combination treatments with other targeted therapies. Recruiting --> Active, not recruiting
- |||||||||| Libtayo (cemiplimab-rwlc) / Regeneron
Enrollment change, Trial completion date, Trial withdrawal, Trial primary completion date: Phase 2 Trial of Maintenance Cemiplimab for Head and Neck Squamous Cell Carcinoma (HNSCC) (clinicaltrials.gov) - Aug 4, 2022 P2, N=0, Withdrawn, Recruiting --> Active, not recruiting N=44 --> 0 | Trial completion date: Sep 2025 --> Jul 2022 | Not yet recruiting --> Withdrawn | Trial primary completion date: Sep 2025 --> Jul 2022
- |||||||||| Review, Journal, PD(L)-1 Biomarker, IO biomarker: The Contributions of Cancer-Testis and Developmental Genes to the Pathogenesis of Keratinocyte Carcinomas. (Pubmed Central) - Jul 29, 2022
CTAs and developmental genes are emerging as important players in the pathogenesis of BCC and cSCC, positioning themselves as attractive candidate biomarkers and therapeutic targets requiring rigorous testing. Herein, we review the current research and offer perspectives on the contributions of CTAs and developmental genes to the pathogenesis of keratinocyte carcinomas.
- |||||||||| BNT116 / BioNTech
LuCa-MERIT-1: First-in-human, open label, phase I dose confirmation trial evaluating the safety, tolerability, and preliminary efficacy of BNT116 alone and in combinations in patients with advanced non-small cell lung cancer (Poster Area, Hall 4) - Jul 28, 2022 - Abstract #ESMO2022ESMO_2345; P1 Secondary endpoints are related to clinical activity, i.e., tumor assessments, as per RECIST 1.1. The first patient is planned to be dosed in May 2022, with enrolment expected for approximately 12 months.
- |||||||||| Libtayo (cemiplimab-rwlc) / Regeneron
Trial completion date, Trial primary completion date: CONTRAC: Cemiplimab in AlloSCT/SOT Recipients With CSCC (clinicaltrials.gov) - Jul 26, 2022 P1, N=12, Recruiting, N=41 --> 61 | Trial completion date: Sep 2023 --> Jan 2024 | Trial primary completion date: Sep 2023 --> Jan 2024 Trial completion date: Jul 2023 --> Jan 2024 | Trial primary completion date: Jul 2022 --> Jan 2023
- |||||||||| BNT112 / BioNTech
Enrollment closed, Monotherapy: PRO-MERIT (Prostate Cancer Messenger RNA Immunotherapy) (clinicaltrials.gov) - Jul 21, 2022 P1/2, N=115, Active, not recruiting, This data is the first report from a Phase 3 study providing therapeutic advantage to pts who progress after 1L PD1 monotherapy. Recruiting --> Active, not recruiting
|