Melanoma

Ongoing and proposed melanoma research will naturally continue to evaluate new treatment types.

The phase 1/2 THETIS clinical trial is actively recruiting patients with metastatic melanoma to be treated with the investigation combination of ATL001 and an immune checkpoint inhibitor.

The phase 3 COMBI-i trial demonstrated that spartalizumab plus dabrafenib and trametinib has modest efficacy in BRAF V600-positive metastatic melanoma, but no progression-free survival benefit when compared with dabrafenib and trametinib alone.

Katherine E. Poruk, MD, reviews the use of complete axillary lymph node dissection and the Multicenter Selective Lymphadenectomy Trial II for Melanoma Monday.

With an FDA orphan drug designation for the treatment of patients with uveal melanoma, darovasertib is being actively investigated in a phase 1/2 clinical trial.

Results from the melanoma cohort the MATINS trial will be shared at the 18th Congress of the European Association of Dermato-Oncology.

For advanced melanoma that is resistant to anti–PD-1 therapies, the addition of BO-112 to pembrolizumab appears to be effective and safe.

Barriers to improving BRAF testing turnaround time in patients with melanoma have been identified in a retrospective analysis of real-world data collected in Canada.

Response were observed with the combination of sotigalimab and pembrolizumab in patients with metastatic melanoma treated in a phase 1/2 study.

According to a phase 1/2 study, nivolumab plus PD-L1/IDO peptide vaccine may be effective for the treatment of patients with metastatic melanoma.

The PROPHETIC trial of a predictive diagnostic analysis platform expanded to a new site at Roswell Park Comprehensive Cancer Center in Buffalo, New York.

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%.