SKIN CANCERS

The combination of tilsotolimod and ipilimumab demonstrated a low objective response rate in patients with anti–PD-1–refractory advanced melanoma, missing the coprimary end point of the phase 3 ILLUMINATE-301 trial.

Nemvaleukin alfa, an interleukin-2 variant immunotherapy for the treatment of mucosal melanoma, has been granted orphan drug designation by the FDA,

The FDA granted Orphan Drug Designation to the novel GPER agonist, LNS8801, for the treatment of patients with metastatic uveal melanoma.

The FDA granted Orphan Drug Designation to cavrotolimod, for the treatment of patients with Merkel cell carcinoma, announced Exicure, Inc, in a press release.

The FDA has granted a Breakthrough Therapy Designation to tebentafusp for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma .

The FDA has approved cemiplimab-rwlc, the PD-1 inhibitor, for the treatment of patients with advanced basal cell carcinoma previously treated with a hedgehog pathway inhibitor or for whom a hedgehog inhibitor is not appropriate.

During a Targeted Oncology Case-Based Peer Perspectives event, Guilherme Rabinowits, MD, medical oncologist/hematologist, Miami Cancer Institute, discussed the case of 69-year-old patients with cutaneous squamous cell carcinoma.

The FDA granted a Fast Track designation to the humanized PD-1 monoclonal antibody toripalimab for the first-line treatment of patients with mucosal melanoma.

The FDA granted 2 Fast Track designations to the cavrotolimod for 2, including in combination with anti-PD-1 therapy in patients with locally advanced or metastatic Merkel cell carcinoma who are refractory to prior anti-PD-1 blockade and in combination with anti-PD-1/PD-L1 in patients with locally advanced or metastatic cutaneous squamous cell carcinoma who are refractory to prior anti-PD-1/PD-L1 blockade.

For patients with cutaneous squamous cell carcinoma who refuse surgery as a treatment for their disease, systemic therapies like cemiplimab, nivolumab, avelumab, and pembrolizumab can still improve outcomes, explained Asim Amin, MD, PhD, a medical oncologist, Levine Cancer Institute. Atrium Health during a Targeted Oncology Case-Based Peer Perspectives event.

Solly Chedid, MD, led a discussion with a group of peers about the treatment of infiltrative basal cell carcinoma in a 88-year-old patient during a Targeted Oncology Case-Based Peer Perspectives event.

The plan of treatment for a 69-year-old patient with poorly differentiated, infiltrative, cutaneous squamous cell carcinoma was the topic of discussion among Dan Paul Zandberg, MD, and other clinicians in attendance during a Targeted Oncology Case-Based Peer Perspectives event.

During a Targeted Oncology Case-Based Peer Perspective event, Chaitali S. Nangia, MD, reviewed the case of a 75-year-old patient with infiltrative basal cell carcinoma.

During a Targeted Oncology Case Based Peer Perspective event, Gino K. In, MD, MPH, assessed the risk status of an 88-year-old patient with basal cell carcinoma and discussed treatment options.

During a Targeted Oncology Case Based Peer Perspective event, Anna C. Pavlick, DO, MS, MBA, discussed the case of a 69-year-old patient with cutaneous squamous cell carcinoma.

The phase 3 COMBI-I clinical trial of spartalizumab plus dabrafenib and trametinib showed no improvement in investigator-assessed progression-free survival in patients with untreated BRAF V600-mutant unresectable or metastatic melanoma, missing the primary end point in part 3 of the study.

In a phase 2 clinical trial, promising clinical activity was observed with cemiplimab in patients with locally advanced basal cell carcinoma who progress on or are intolerant to hedgehog inhibitors, regardless of PD-L1 expression, according to findings presented at the 2020 ESMO Virtual Congress.

Treatment options for a 69-year-old patient with poorly differentiated, infiltrative, cutaneous squamous cell carcinoma was discussed by Meredith McKean, MD, MPH and a group of physicians.

Mark Agulnik, MD, discussed the guidelines and data supporting possible treatment decisions for an 88-year-old male patients with basal cell carcinoma, during a virtual Case Based Peer Perspectives event.

Progression-free survival was not improved with the combination of spartalizumab, dabrafenib, and trametinib when administered as treatment of untreated patients with unresectable or metastatic BRAF V600E-mutant cutaneous melanoma compared with dabrafenib plus trametinib alone, missing the primary end point of the phase 3 COMBI-I clinical trial.

The FDA has granted Fast Track designation to CMP-001 in combination with nivolumab plus ipilimumab under 2 melanoma indications.

A guideline from the American Society of Clinical Oncology addresses 4 clinical questions regarding approaches to systemic treatment for different types and stages of melanoma, in addition to summarizing the trials on which the recommendations were based.

A retrospective 10-year analysis of 3 randomized clinical trials explored the question of whether BRAF V600E/K mutations or previous use of a BRAF inhibitor with or without a MEK inhibitor in patients with metastatic disease impacted patient response to pembrolizumab.

In an interview with Targeted Oncology, Danny Rischin, MD, director, discussed the findings from the EMPOWER-CSCC-1 study of cemiplimab in advanced cutaneous squamous cell carcinoma that led to the drug’s FDA approval.

In patients with advanced melanoma whose disease progressed on immunotherapy, the use of fecal microbiota transplant achieved objective responses, in a phase I study.

Pembrolizumab received FDA approval for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma that cannot be cured by either surgery or radiation.

With a Fast Track designation, the development of seviprotimut-L will be facilitated and expeditiously reviewed by the FDA to address an unmet medical need for patients with stage IIB and IIIC melanoma,

“The data demonstrated deepening clinical responses with cemiplimab over time. Furthermore, duration of response and overall survival [OS] are considerably longer with cemiplimab than what has previously been recorded with other agents.”

"...These important new results further demonstrate Libtayo’s potential in patients with difficult-to-treat, non-melanoma skin cancers."

In an interview with Targeted Oncology, Bruce L. Levine, PhD, discussed hot topics in the treatment landscape of melanoma, including the development of chimeric antigen receptor T and NK cells.