Melanoma

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 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 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 an Orphan Drug designation to the novel immunotherapy PVSRIPO for the treatment of patients with advanced melanoma of stage IIB-IV.

ONCOS-102 plus pembrolizumab demonstrated promising objective responses as treatment of patients with anti-PD1–refractory malignant melanoma.

Overall survival was statistically significantly improved with tebentafusp compared with investigator’s choice of therapy as treatment of patients with metastatic uveal melanoma in the phase 3 IMCgp100-202 study.

The strategy of adding the plasmid IL-12 agent tavokinogene telseplasmid to pembrolizumab led to deep systemic responses in patients with actively progressing anti–PD-1–refractory advanced melanoma, according to interim results from the KEYNOTE-695 clinical trial.

During a virtual presentation for the 38th Annual Chemotherapy Foundation Symposium, Janice M. Mehnert, MD explained the science behind selecting the optimal adjuvant therapy for patients with BRAF-mutant melanoma. The options Mehnert weighed were immunotherapy and BRAF-targeted therapy.

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.

The primary end point of investigator-assessed progression-free survival was missed in part 3 of the randomized, Phase 3 COMBI-i study of spartalizumab in combination with dabrafenib and trametinib in patients with untreated BRAF V600-mutant unresectable or metastatic melanoma, according to results presented at the 2020 ESMO Virtual Congress.

The use of encorafenib and binimetinib followed by immunotherapy demonstrated a higher progression-free survival, as well as an objective response rate and median PFS at 1 and 2 years that were consistent with those reported in pivotal studies, according to a presentation by Paolo Ascierto, MD, at the 2020 ESMO Virtual Congress.

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.

Frontline treatment with the immune checkpoint inhibitor pembrolizumab as monotherapy generated promising activity against cutaneous squamous cell carcinoma with durable responses and a manageable safety profile.

The final data of a personalized tumor lysate, particle-loaded, dendritic cell vaccine demonstrated that patients with stage III or IV melanoma with high-risk of recurrence after complete surgical resection had better survival benefit and disease-free survival rate with the vaccine over placebo, according to a press release from Elios Therapeutics.

The FDA granted approval to atezolizumab in combination with cobimetinib and vemurafenib for the treatment of patients with BRAF V600E-mutated advanced melanoma.

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.

In an interview with Targeted Oncology, following the tweet chat, Shoushtari highlighted the key takeaways from the tweet chat discussion and spoke to how he would make his own treatment decisions for this patient scenario.

Christian U. Blank, MD, PhD, discusses the most recent data from the phase 1b OpACIN trial of ipilimumab and nivolumab in patients with macroscopic stage III melanoma.

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.

The phase 2 basket arm trial of IDE196 in patients with solid tumors harboring GNAQ or GNA11 hotspot mutations has met its clinical protocol criteria for cohort expansion.

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

Axel Hauschild, MD, PhD, discusses the key findings from the phase 3 COMBI-AD clinical trial, which demonstrated sustained long-term relapse-free survival benefit with the combination of dabrafenib and trametinib compared with placebo in patients with resected, stage III BRAF V600E/K-mutated melanoma.

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,