Melanoma

Alrizomadlin, a MDM2-p53 inhibitor has been granted a fast track designation by the FDA for the treatment of relapsed/refractory unresectable or metastatic melanoma who are relapsed or refractory to prior immune-oncologic agents.

Compared with a placebo, adjuvant pembrolizumab led to a significant reduction in the risk of disease recurrence or death in patients with resected, high-risk stage II melanoma.

In previously untreated patients with metastatic or unresectable melanoma, the addition of relatlimab to nivolumab prolonged benefit beyond initial treatment and first progression and reduced the risk of progression or death after the next line of systemic therapy vs nivolumab alone.

The FDA has accepted the biologics license application for tebentafusp and granted it priority review for the treatment of adult patients with HLA-A*02:01-positive metastatic uveal melanoma.

Combination treatment with the universal cancer vaccine, UV1, and the immune checkpoint inhibitor, pembrolizumab showed strong signals of clinical response in patients with metastatic melanoma while also meeting its key safety/tolerability end point.

The FDA has accepted and granted priority review to a biologics license application for pembrolizumab for the adjuvant treatment of adult and pediatric patients with stage IIB or IIC melanoma following complete resection.

The FDA has granted a fast track designation for nemvaleukin alfa, an interleukin-2 variant immunotherapy, for the treatment of mucosal melanoma.

Cutaneous melanoma is disproportionately lethal among skin cancers, and as incidence rates of cutaneous melanoma continue to rise in the United States, so does the importance of managing melanoma cases in alignment with personalized prognoses.

The FDA has granted an orphan drug designation to alrizomadlin, an MDM2-p53 inhibitor, for the treatment of stage 2b to 4 melanoma.

According to Inge Marie Svane, MD, PhD, the truth about what drives tumor-infiltrating lymphocyte efficacy is not yet known, and more research is needed.

Research has suggested that neoadjuvant immunotherapy combinations are superior to adjuvant immunotherapy for patients with stage III melanoma.

Targeted therapy use in melanoma has been extended beyond just metastatic disease to now include adjuvant therapy for patients with resected stage III melanoma.

The combination of alrizomadlin and pembrolizumab was well tolerated in patients with unresectable or metastatic melanoma or advanced solid tumors that have been resistant to immuno-oncologic drugs treated in a phase 2 study.

Looking at 6.5 years of follow-up data from the phase 3 CheckMate-067 trial shows maintained outcomes in patients with advanced melanoma on nivolumab alone, or with ipilimumab.

Further follow up of lifileucel in patients with melanoma showed potentially follow progression on anti—PD-1 therapy.

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.