Melanoma | Clinical

Early Efficacy of Darovasertib +/- Binimetinib Better Than Historical Controls for Metastatic Uveal Melanoma

April 16, 2021

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.

Lifileucel TIL Therapy Demonstrates Durable Responses in Pretreated Advanced Melanoma

April 11, 2021

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.

Initial Treatment With Tebentafusp Show Significant OS Improvement in Metastatic Uveal Melanoma

April 10, 2021

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.

Fixed-Dose Relatlimab Plus Nivolumab Shows First Signs of Benefit in Advanced Melanoma

March 26, 2021

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.

Breakthrough Device Designations Granted to Novel MRD Test, Signatera

March 25, 2021

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

Tilsotolimod Plus Ipilimumab Shows Suboptimal Responses in Anti–PD-1 Refractory Advanced Melanoma

March 19, 2021

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 for Mucosal Melanoma Granted FDA’s Orphan Drug Status

March 12, 2021

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

FDA’s Orphan Drug Status Granted to LNS8801 for Metastatic Uveal Melanoma

March 10, 2021

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

Tebentafusp Granted FDA Breakthrough Therapy Designation for Unresectable or Metastatic Uveal Melanoma

February 19, 2021

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 .

FDA ‘Fast Tracks’ Toripalimab in Frontline Mucosal Melanoma

January 25, 2021

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.