ASCO 2015 Highlights

On December 22, 2022, the FDA accelerated the approval of mosunetuzumab-axgb (Lunsumio; Genentech), a bispecific CD20-directed CD3 T-cell engager, for adults with relapsed or refractory follicular lymphoma after ≥2 lines of systemic therapy. The FDA granted this indication breakthrough therapy and orphan drug designations.

On December 12, 2022, the FDA accelerated the approval of adagrasib (Krazati; Mirati Therapeutics), a RAS GTPase inhibitor, for adults with locally advanced or metastatic non–small-cell lung cancer (NSCLC) and KRAS^G12C mutation (as determined by an FDA-approved test) who have received at least 1 systemic therapy.

On January 26, 2023, the FDA approved pembrolizumab (Keytruda; Merck), a PD-1 inhibitor, as monotherapy for adjuvant treatment of patients with stage IB (T2a ≥4 cm), II, or IIIA non–small-cell lung cancer (NSCLC), after resection and platinum-based chemotherapy.

On January 19, 2023, the FDA accelerated the approval of tucatinib (Tukysa; Seagen), a Bruton tyrosine kinase inhibitor, in combination with trastuzumab (Herceptin), a HER2/neu receptor agonist, for the treatment of RAS wild-type, HER2-positive, unresectable or metastatic colorectal cancer (CRC) that progressed after fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapies.

On January 19, 2023, the FDA approved zanubrutinib (Brukinsa; BeiGene USA), a Bruton tyrosine kinase (BTK) inhibitor, for the treatment of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The FDA granted zanubrutinib an orphan drug designation for this indication.

On December 9, 2022, the FDA approved atezolizumab (Tecentriq; Genentech), a PD-L1 inhibitor, for patients aged ≥2 years with unresectable or metastatic alveolar soft-part sarcoma (ASPS), a type of soft-tissue sarcoma.

Patients undergoing hematopoietic stem-cell transplantation (HSCT) do not derive any benefit from the restrictive diet frequently prescribed to prevent infections, according to the results of a clinical trial presented during the 64th American Society of Hematology Annual Meeting and Exposition.

Response to treatment with a regimen of daratumumab (Darzalex) plus lenalidomide (Revlimid; DR) was greater and minimal residual disease (MRD) was achieved more frequently compared with a regimen of lenalidomide plus dexamethasone (Rd) in the first randomized phase 3 clinical trial dedicated to frail, transplant-ineligible patients with newly diagnosed multiple myeloma.

Using circulating tumor cell (CTC) count to guide the choice of first-line treatment—chemotherapy or endocrine therapy—improved overall survival (OS) compared with investigator’s choice of treatment for patients with metastatic, estrogen receptor (ER)-positive, HER2-negative breast cancer, according to results from the STIC CTC trial, which were discussed at the 2022 San Antonio Breast Cancer Symposium (SABCS) by François-Clément Bidard, MD, PhD, Co-Coordinator, Breast Cancer Research, Institut Curie, Paris, France, and Professor, Medicine, Department of Medical Oncology, Institut Curie and Université de Versailles Saint-Quentin-en-Yvelines, France.

At the 4th Annual Cholangiocarcinoma Summit, held on October 13-15, 2022, in Aurora, CO, experts in the field of gastroenterology, interventional radiology, nursing, and surgery discussed the importance of using a multidisciplinary approach to supportive care and the management of complications in patients with biliary tract cancers (BTCs).