ASCO 2015 Highlights

Approximately 13% of patients with lung adenocarcinomas harbor KRAS p.G12C mutations. In the phase 2 CodeBreaK 100 clinical trial, the responses to sotorasib in patients with advanced non–small-cell lung cancer (NSCLC) and KRAS p.G12C mutation were early, deep, and durable, according to Bob T. Li, MD, PhD, MPH, Medical Oncologist, Thoracic Oncology Service, Memorial Sloan Kettering Cancer Center, New York, NY. He presented the study results at the 2021 International Association for the Study of Lung Cancer meeting.

Sexual orientation and assigned sex at birth are significant determinants in the utilization of lung cancer screening, according to an analysis from the Behavioral Risk Factor Surveillance System (BRFSS) 2018, a cross-sectional, nationally representative database, that looked at screening among lesbian, gay, bisexual, transgender (LGBT) populations.

Genomic analysis of lung cancer in women who have never smoked may reveal novel mutations and structural alterations. Such an analysis, said Sitapriya Moorthi, PhD, Human Biology, Fred Hutchinson Cancer Research Center, Seattle, WA, may suggest unique opportunities for future target identification and therapeutic intervention. Dr Moorthi discussed the results of a mutational analysis of the Women’s Health Initiative Cohort that were presented at the 2021 International Association for the Study of Lung Cancer meeting.

For patients with relapsed malignant mesothelioma, nivolumab (Opdivo) monotherapy is an effective treatment option, according to preliminary results of the phase 3 CONFIRM study, presented at the 2021 International Association for the Study of Lung Cancer meeting.

On March 27, 2021, the FDA approved idecabtagene vicleucel (Abecma; Bristol Myers Squibb/Bluebird Bio), a B-cell maturation antigen (BCMA)-directed, genetically modified autologous chimeric antigen receptor (CAR) T-cell therapy, for the treatment of adults with multiple myeloma whose disease did not respond to, or recurred, after ≥4 lines of therapy. Idecabtagene vicleucel is the first cell-based gene therapy approved by the FDA for the treatment of multiple myeloma. The FDA granted this indication orphan drug and breakthrough therapy designations.

On February 26, 2021, the FDA accelerated the approval of melphalan flufenamide (Pepaxto; Oncopeptides AB), an alkylating drug, for the treatment, in combination with dexamethasone, of adults with relapsed or refractory multiple myeloma who have received ≥4 lines of therapy and whose disease is triple-refractory to ≥1 proteasome inhibitors, 1 immunomodulatory drug, and 1 CD-38–directed monoclonal antibody.

On February 12, 2021, the FDA approved trilaciclib (Cosela; G1 Therapeutics), as a first-in-class cyclin-dependent kinase (CDK)4/6 inhibitor to reduce the frequency of chemotherapy-induced myelosuppression in adults with extensive-stage small-cell lung cancer, when used before a platinum plus etoposide regimen or a topotecan-containing regimen. Trilaciclib may prevent damage to bone marrow cells by inhibiting the CDK4/6 enzyme. The FDA granted trilaciclib priority review and a breakthrough therapy designation.

On February 5, 2021, the FDA approved lisocabtagene maraleucel (Breyanzi; Juno Therapeutics), a new CD19-directed chimeric antigen receptor (CAR) T-cell therapy, for the treatment of adults with relapsed or refractory large B-cell lymphoma (LBCL) after ≥2 previous lines of systemic therapy. The FDA granted lisocabtagene maraleucel priority review, as well as breakthrough therapy, orphan drug, and regenerative medicine advanced therapy designations.

On February 5, 2021, the FDA approved umbralisib (Ukoniq; TG Therapeutics), an oral kinase inhibitor, for the treatment of adults with relapsed or refractory marginal-zone lymphoma (MZL) or with relapsed or refractory follicular lymphoma (FL). Umbralisib is indicated for MZL after ≥1 CD20-directed regimens, and for FL after ≥3 lines of systemic therapy.

On March 30, 2021, the FDA approved a new indication for daunorubicin and cytarabine (Vyxeos; Jazz Pharmaceuticals) for the treatment of pediatric patients aged ≥1 years with newly diagnosed, therapy-related acute myeloid leukemia (AML) or patients with AML and myelodysplasia-related changes. Daunorubicin and cytarabine is a liposomal combination of an anthracycline topoisomerase inhibitor (daunorubicin) and a nucleoside metabolic inhibitor (cytarabine).