Articles

On January 25, 2022, the FDA accelerated the approval of tebentafusp-tebn (Kimmtrak; Immunocore), a bispecific gp100 peptide-HLA–directed CD3 T-cell engager, for the treatment of adult patients with HLA-A*02:01 unresectable or metastatic uveal (intraocular) melanoma.

On March 21, 2022, the FDA approved a new indication for the PD-1 inhibitor pembrolizumab (Keytruda; Merck) as monotherapy for advanced endometrial carcinoma that is microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), as determined by an FDA-approved test, in patients whose disease progressed after previous systemic therapy in any setting and who are not candidates for curative surgery or radiation.

On March 11, 2022, the FDA accelerated the approval of the oral PARP inhibitor olaparib (Lynparza; AstraZeneca) for the adjuvant treatment of adults with HER2-negative, high-risk early breast cancer and deleterious or suspected deleterious germline BRCA mutation after neoadjuvant or adjuvant chemotherapy. Patients must be selected for olaparib therapy for this indication based on an FDA-approved test.

On March 4, 2022, the FDA accelerated the approval of the PD-1 inhibitor nivolumab (Opdivo; Bristol Myers Squibb) in combination with platinum-doublet chemotherapy for the neoadjuvant treatment of adults with resectable non–small-cell lung cancer (NSCLC). This represents the first FDA approval for neoadjuvant therapy for early-stage NSCLC.

Two years of abiraterone acetate (Zytiga) plus prednisone added to androgen-deprivation therapy (ADT) improved metastasis-free survival and overall survival compared with ADT alone in men with nonmetastatic castration-sensitive prostate cancer, whereas the addition of enzalutamide (Xtandi) to ADT had no benefit, and much greater toxicity.

Adagrasib (MRTX849), an inhibitor of the KRAS^G12C mutation, showed promising activity as monotherapy and in combination with cetuximab (Erbitux) in patients with metastatic colorectal cancer (CRC) in the phase 1/2 KRYSTAL-1 trial.

Vaccination with the mRNA-1273 vaccine (Moderna) appears safe in patients with solid tumors receiving immunotherapy, chemotherapy, or chemoimmunotherapy.

Second-line therapy with trastuzumab deruxtecan (Enhertu; T-DXd) extended progression-free survival (PFS) and improved objective response rate (ORR) versus trastuzumab emtansine (Kadcyla; T-DM1) in women with HER2-positive metastatic breast cancer, including those with stable brain metastasis at baseline, according to a subgroup analysis of a phase 3 clinical trial.

Final results from the pivotal phase 3 KEYNOTE-355 trial showed that the addition of pembrolizumab (Keytruda) to chemotherapy resulted in a statistically significant and clinically meaningful improvement in overall survival (OS) compared with chemotherapy alone in patients with metastatic triple-negative breast cancer (TNBC) whose tumors expressed PD-L1 with a combined positive score (CPS) ≥10.