ASCO 2015 Highlights

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.

The subtypes of cholangiocarcinoma (CCA), including intrahepatic CCA and extrahepatic CCA, have various underlying tumor microenvironments, pathobiology, epidemiologic features, and risk factors; however, the genetic underpinnings of the CCA subtypes have not been previously defined.

Updates to the screening guidelines for colorectal cancer (CRC) from the National Comprehensive Cancer Network (NCCN) include lowering the initial screening age for average-risk individuals and second- and third-degree family members with CRC, as well as an extension in the interval for surveillance colonoscopy for low-risk individuals.