Melanoma

The FDA has granted approval to the fixed-dose combination of relatlimab plus nivolumab for the treatment of adult and pediatric patients with unresectable or metastatic melanoma.

Relatlimab plus nivolumab demonstrated reduction in risk of progression or death and numerically improved overall survival compared to nivolumab alone.

All primary end points in the phase 3 study of bempegaldesleukin plus nivolumab for the treatment of metastatic melanoma were missed, but analyses are ongoing.

In PIVOT IO-001, patients with metastatic melanoma are no longer being enrolled and treatment arms have been unblinded after the combination of bempegaldesleukin and nivolumab did not meet its coprimary end points.

Fast track designation has been granted to 7HP349, in combination with a CTLA-4 inhibitor for the treatment of patients with unresectable or metastatic malignant melanoma following treatment failure with a PD-1 inhibitor.

Pembrolizumab given in the adjuvant setting to patients with resected stage IIB and IIC melanoma shows benefit over placebo.

In an interview with Targeted Oncology, Michael A. Postow, MD, summarized the treatment landscape, provided takeaways from the most recent additions, and discussed other targets for metastatic melanoma.

Tebentafusp-tebn has been granted FDA approval to treat HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma based on positive results from a phase 3 study.

Efficacy was seen with blocking LAG-3 in combination with PD-1 as a therapeutic strategy for patients with melanoma. Additionally, this research establishes LAG-3 as the third immune checkpoint pathway to have proven clinical benefit in this patient population.

ST101 was granted a fast track designation based on preliminary data of an ongoing phase 1/2 trial.

Darovasertib and crizotinib demonstrated promising efficacy and tolerable safety in patients with metastatic uveal melanoma, according to preliminary results of a phase 1/2 trial announced in a press release from IDEAYA Biosciences.

In the phase 3 FOCUS study, a positive result for a secondary end point was observed with melphalan hydrochloride for injection in patients with liver-dominant metastatic ocular melanoma.

Pembrolizumab for stage IIB or IIC melanoma has been granted approval by the FDA.

BNT111, an immunotherapy agent under investigation in a phase 2 study, has been granted fast track designation by the FDA.

During the November 2021 Session of the American Society of Clinical Oncology Plenary Series, Michael B. Atkins, MD, presented data from the DREAMseq study, which compared 2 treatment sequences for advanced BRAF-mutant melanoma.

The CheckMate 204 study showed overall survival benefit of combination nivolumab/ipilimumab to patients with melanoma brain metastases.

Phase 2 results presented during the SITC Annual Meeting show that adding intratumoral BO-112 to pembrolizumab in patients with advanced melanoma can induce durable responses.

A fast-track designation was granted to a universal cancer vaccine in combination with checkpoint inhibitors. The vaccine, UV1, can be used in combination with either pembrolizumab or ipilimumab.

The combination had a 24-month OS rate of 80%.

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.