Adjuvant Therapy

Osimertinib demonstrated “overwhelming efficacy” for the adjuvant treatment of patients with stage IB, II and IIIA epidermal growth factor receptor-mutated non-small cell lung cancer after complete tumor resection, according to a press release issued by the agent’s manufacturer.

Following the promising findings of the second interim analysis of the randomized phase 3 SOPHIA trial — presented at San Antonio Breast Cancer Symposium in December 2019 — the manufacturer of the investigational agent, margetuximab, submitted a biologics license application for use in patients with metastatic HER2-positive breast cancer.

Adjuvant ipilimumab dosed at 3 mg/kg significantly improved OS compared with high-dose interferon alfa-2b among patients with metastatic unresectable melanoma, according to results of the phase 3 E1609 trial published in Journal of Clinical Oncology.

The randomized phase 3 APACT trial was a well-designed adjuvant trial that evaluated the addition of nab-paclitaxel (Abraxane, Celgene) to gemcitabine — the combination was planned based upon the positive results of the MPACT trial in the metastatic setting. Interestingly, around the same time as the MPACT trial, FOLFIRINOX also showed improved OS in the metastatic setting compared with single-agent gemcitabine. Although median survival with FOLFIRINOX appeared to be numerically superior than with gemcitabine and nab-paclitaxel, subsequent real-world analyses indicated no significant differences in OS or time to treatment failure between the two regimens. It is therefore surprising that although the adjuvant FOLFIRINOX study was positive, the adjuvant gemcitabine and nab-paclitaxel trial was not.

Approximately 20% to 25% of human breast cancers are marked by an acquired alteration or over-expression in the HER2 gene. While HER2-positive tumors can be aggressive, researchers and clinicians have developed an armamentarium of several drugs, as well as combination therapy approaches, to attack this disease.

Findings from a recent retrospective study demonstrated a multiyear decline in the population-level mortality of melanoma. This decline has been associated with the FDA approval of 10 novel treatments for metastatic melanoma since 2011.