ASCO 2015 Highlights

On November 6, 2017, the FDA approved alectinib (Alecensa; Genentech) for the treatment of patients with ALK mutation–positive, metastatic non–small-cell lung cancer (NSCLC), as detected by an FDA-approved test. On the same day, the FDA also converted alectinib’s initial accelerated approval to a full approval for the treatment of patients with metastatic NSCLC and ALK mutation whose disease progressed with or who were intolerant of crizotinib (Xalkori).

On October 31, 2017, the FDA granted accelerated approval to acalabrutinib (Calquence; AstraZeneca) for the treatment of adults with mantle-cell lymphoma (MCL) who have received at least 1 previous therapy. The FDA granted acalabrutinib priority review and breakthrough therapy and orphan drug designations for this indication.

On September 28, 2017, the FDA approved abemaciclib (Verzenio; Eli Lilly), a cyclin-dependent kinase (CDK)4/CDK6 inhibitor, in combination with fulvestrant, for the treatment of women with hormone receptor (HR)-positive, HER2-negative advanced or metastatic breast cancer that progressed after endocrine therapy, and as monotherapy for HR-positive, HER2-­negative advanced or metastatic breast cancer that progressed after endocrine therapy and previous chemotherapy in the metastatic setting.

On October 18, 2017, the FDA approved axicabtagene ciloleucel (Yescarta; Kite Pharma), a CD19-directed genetically modified CAR T-cell immunotherapy, for the treatment, after ≥2 lines of systemic therapies, of adults with several types of relapsed or refractory large B-cell lymphoma, including (1) diffuse large B-cell lymphoma (DLBCL) not otherwise specified, (2) primary mediastinal large B-cell lymphoma, (3) high-grade B-cell lymphoma, and (4) DLBCL arising from follicular lymphoma.

On September 14, 2017, the FDA granted accelerated approval to copanlisib (Aliqopa; Bayer Healthcare) for the treatment of adults with relapsed follicular lymphoma who have received ≥2 previous systemic therapies. Copanlisib received priority review and an orphan drug designation for this indication.

Based on an unplanned post-hoc subset analysis of the CALGB 10603/RATIFY trial, the clinical benefit of maintenance therapy following midostaurin plus induction and consolidation chemotherapy for newly diagnosed patients with FLT3 mutations could not be discerned.

Combination treatment with nivolumab plus azacitidine produced encouraging response rates in patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) with poor-risk features, and in elderly patients as frontline therapy.

A phase 1 dose-escalation study of FLX925, a dual FLT3 and CDK4/6 inhibitor, showed modest antileukemic activity in adult patients with relapsed or refractory acute myeloid leukemia (AML).

An analysis of response and survival outcomes from the phase 1/2 AG221-C-001 study showed that continued treatment with enasidenib resulted in improved survival and response times in patients with mutant-IDH2 relapsed or refractory (R/R) acute myeloid leukemia (AML).

The results of the current phase 1b/2 study showed that the combination of azacitidine plus lirilumab was well-tolerated in heavily pretreated patients with relapsed acute myeloid leukemia (AML) and poor-risk disease features.