October 2021, Vol 12, No 5

On September 15, 2021, the FDA accelerated the approval of mobocertinib (Exkivity; Takeda Pharmaceuticals), a tyrosine kinase inhibitor, for the treatment of adults with locally advanced or metastatic non−small-cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations, as detected by the FDA-approved Oncomine Dx Target Test (Life Technologies Corporation), which was approved on the same day as a companion diagnostic for mobocertinib. The FDA granted mobocertinib priority review, breakthrough therapy designation, and orphan drug designation.

Oropharyngeal cancer, which can develop at the base of the tongue, tonsils, and the middle part of the throat, is primarily caused by human papillomavirus (HPV) infection, the most common sexually transmitted virus and infection in the United States. Over the past 2 decades, cases of HPV-positive oropharyngeal squamous-cell carcinoma (OPSCC) have been increasing at an alarming rate among men in the United States. According to the American Cancer Society, approximately 54,000 cases of oropharyngeal and oral cavity cancer will be diagnosed in the United States in 2021, and more than 10,000 individuals will die from the disease. OPSCC is often diagnosed at an advanced stage, resulting in increased mortality and morbidity.

Cancer remains the leading cause of death in individuals aged <80 years in the United States, and was responsible for nearly 10 million deaths worldwide in 2020.1,2 According to the National Cancer Institute, the 5-year survival rate for individuals diagnosed with localized cancer of any type is 89%.3 However, this rate drops to only 21% for those diagnosed with metastatic disease,3 highlighting the detrimental impact of late-stage diagnosis on patient outcomes.

Neoadjuvant nivolumab (Opdivo) plus chemotherapy significantly improved pathologic complete response (pCR) rates versus chemotherapy alone in patients with resectable stage IB-IIIA non–small-cell lung cancer (NSCLC), according to final results from the CheckMate-816 clinical trial. These findings were presented by Patrick Forde, MBBCh, Associate Professor of Oncology and Director of the Thoracic Cancer Clinical Research Program at Johns Hopkins University Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD, during the virtual 2021 American Association for Cancer Research Annual Meeting.

Approximately 13% of patients with lung adenocarcinoma harbor the KRAS p.G12C mutation, which is associated with poor clinical outcomes. During the American Society of Clinical Oncology 2021 virtual annual meeting, Ferdinandos Skoulidis, MD, PhD, MRCP, Assistant Professor, Thoracic/Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, provided updated results from the phase 2 component of the CodeBreaK 100 clinical trial, which evaluated sotorasib (Lumakras), a small-molecule inhibitor of the KRAS p.G12C mutation, in previously treated patients with non–small-cell lung cancer (NSCLC) whose tumors express this aberration. These results were simultaneously published in the New England Journal of Medicine.

The addition of the PI3K inhibitor copanlisib (Aliopa) to rituximab (Rituxan) reduced the risk for disease progression or death by 48% compared with placebo plus rituximab in patients with relapsed indolent non-Hodgkin lymphoma (NHL) in the phase 3 CHRONOS-3 clinical trial. The results of this study were presented at the 2021 virtual American Association for Cancer Research (AACR) annual meeting and published simultaneously in Lancet Oncology.

According to the American Cancer Society, nearly 35,000 new cases of multiple myeloma will be diagnosed in the United States in 2021, and approximately 12,410 deaths will be attributed to the disease.1 However, with the introduction of several novel therapies, the outcomes for patients with newly diagnosed multiple myeloma have improved significantly over the past decade.

On July 26, 2021, the FDA accelerated the approval of a new indication for the PD-1 inhibitor pembrolizumab (Keytruda; Merck) for the treatment of patients with high-risk, early-stage, triple-negative breast cancer (TNBC) in combination with chemotherapy as a neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery.