Melanoma

In an updated analysis of the combination of lenvatinib and pembrolizumab for patients with advanced melanoma, efficacy results continue to show a durable response.

Treatment-naïve patients with melanoma who crossed over to receive pembrolizumab had an ORR of 38.8% and a 3-year PFS of 32% according to updated data from the phase 3 EORTX 1325/KEYNOTE-054 trial.

PFS Doubles for Advanced Melanoma Patients Treated with Relatlimab Plus Nivolumab.

Novel methods of genetic testing have led to improved detection and better clinical decisions in patients with melanoma, especially in the late-stage setting.

Annelise Wilhite, MD, discusses a clinical investigation of survival in patients with vulvar/vaginal melanomas.

In an interview with Targeted Oncology, Zeynep Eroglu, MD, discussed recent advances in melanoma treatment, exciting upcoming studies, and the evolving melanoma landscape.

The FDA has granted orphan drug designation to ITIL-168 for the treatment of stage IIB to IV melanoma, an investigational, autologous cell therapy derived from tumor-infiltrating lymphocytes.

Darovasertib, a selective protein kinase C inhibitor, demonstrated promising response rates, survival, and reduction in tumor size as treatment of patients with metastatic uveal melanoma treatment both alone and in combination with binimetinib, according to preliminary results from a 7-armed phase 1/2 clinical trial.

In the phase 2 C-144-01 trial, patients had durable responses to treatment with the tumor-infiltrating lymphocyte lifileucel after more than 28 months of follow-up.

In patient with metastatic uveal melanoma, frontline treatment with tebentafusp achieved significant and clinically meaningful improvement in overall survival, according to data from the phase 3 IMCgp100-202 trial.

The RELATIVITY-047 study reached its primary endpoint for the fixed dose combination of relatlimab and nivolumab for patients with previously untreated metastatic or unresectable melanoma.

The FDA has granted 2 breakthrough device designations to the molecular residual disease test, Signatera.

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 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.