Melanoma | Clinical

FDA Grants Orphan Drug Designation to Novel Immunotherapy in Advanced Melanoma

January 11, 2021

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 Induces Impressive Responses in Anti-PD1–Refractory Melanoma

December 02, 2020

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

Phase 3 Study Shows Statistically Significant Survival With Tebentafusp in Metastatic Uveal Melanoma

November 24, 2020

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.

Plasmid IL-12 Added to Pembrolizumab Elicits Deep and Durable Responses in Advanced Melanoma

November 11, 2020

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.

Selecting I/O or Targeted Therapy as Adjuvant Treatment of BRAF-Mutant Melanoma

November 05, 2020

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.

Spartalizumab Triplet Does Not Improve PFS in Metastatic Melanoma

September 20, 2020

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.

PFS End Point Missed With Spartalizuamb, Dabrafenib, and Trametinib in Melanoma

September 19, 2020

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.

Sequencing Immunotherapy After Encorafenib and Binimetinib Showed Higher PFS in Metastatic Melanoma

September 19, 2020

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.

COMBI-i Regimen Does Not Improve PFS in Unresectable or Metastatic BRAF V600E-Mutant Melanoma

August 24, 2020

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.

First-Line Pembrolizumab Demonstrates Promising Activity in Phase 2 of Cutaneous Squamous Cell Carcinoma

August 07, 2020

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.