June 2022, Vol 13, No 3

The phase 3 CheckMate-816 trial establishes a new standard of care for resectable non–small-cell lung cancer (NSCLC): neoadjuvant nivolumab (Opdivo) plus chemotherapy.

Treatment with the androgen receptor inhibitor darolutamide (Nubeqa), in combination with androgen-deprivation therapy (ADT) and docetaxel, significantly improved overall survival (OS) compared with ADT and docetaxel alone in patients with metastatic hormone-sensitive prostate cancer (mHSPC), according to recent results from the phase 3 ARASENS clinical trial, which were simultaneously published in the New England Journal of Medicine.

The global, double-blind, placebo-controlled, phase 3 TOPAZ-1 clinical trial evaluated the first-line chemoimmunotherapy regimen of the PD-L1 inhibitor durvalumab (Imfinzi) plus gemcitabine and cisplatin in patients with advanced biliary tract cancer.

A team of researchers in Germany has developed a multipeptide COVID-19 vaccine that boosts immunity in immunocompromised patients, according to results of a phase 1/2 trial reported at the 2022 American Association for Cancer Research annual meeting.

On May 27, 2022, the FDA accelerated the approval of a new indication for the CD19-directed CAR T-cell therapy tisagenlecleucel (Kymriah; Novartis) for adults with relapsed or refractory follicular lymphoma after ≥2 lines of systemic therapy.

On May 25, 2022, the FDA accelerated the approval of ivosidenib tablets (Tibsovo; Servier Pharmaceuticals), in combination with azacitidine tablets (Onureg; Celgene) for newly diagnosed acute myeloid leukemia (AML) and a susceptible IDH1 mutation, as detected by an FDA-approved test, in patients aged ≥75 years, or patients with comorbidities that preclude the use of intensive induction chemotherapy.

On May 20, 2022, the FDA accelerated the approval of a new indication for azacitidine injection (Vidaza; Celgene) for the treatment of pediatric patients with newly diagnosed juvenile myelomonocytic leukemia (JMML).

On May 4, 2022, the FDA granted a regular full approval for fam-trastuzumab deruxtecan-nxki (Enhertu; Daiichi Sankyo), an HER2-directed antibody and topoisomerase inhibitor conjugate, for the treatment of adults with unresectable or metastatic HER2-positive breast cancer who had received a prior anti–HER2-based regimen either in the metastatic setting, or in the neoadjuvant or adjuvant setting and who had developed disease recurrence during or within 6 months of completing therapy.

On April 1, 2022, the FDA accelerated the approval of a new indication for the CAR T-cell therapy axicabtagene ciloleucel (Yescarta; Kite Pharma) for adults with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or relapses within 12 months of first-line chemoimmunotherapy.

The use of a polygenic score (PGS) based on noncancer genetic variations in prostate-specific antigen (PSA) values helped to refine PSA screening in a large group of men without prostate cancer at baseline. The use of the PGS to adjust PSA allows identification of aggressive versus low-risk prostate cancer and can potentially reduce unnecessary biopsies, said the lead investigator of a large genome-wide association study (GWAS) presented at the 2022 American Association for Cancer Research annual meeting.