Articles

San Francisco, CA—Patients with ovarian cancer can respond to immunotherapy, but rationally designed synergistic combinations will be necessary to enhance upfront efficacy and to sustain durability, said Daniel J. Powell Jr, PhD, Scientific Director of Immunotherapy, Division of Gynecologic Oncology, Center for Cellular Immunotherapy, University of Pennsylvania, Philadelphia, at the 2019 ASCO-SITC Clinical Immuno-Oncology Symposium.

Atlanta, GA—Chimeric antigen receptor (CAR) T-cell therapy has had dramatic results in hematologic malignancies, but so far, getting CAR T-cells to work in solid tumors has proved elusive. That may be about to change if promising results from a phase 1 clinical trial are confirmed by further studies. The results of this pivotal study were presented at the 2019 American Association for Cancer Research (AACR) annual meeting.

Atlanta, GA—Preclinical and clinical data support the potential for the investigational novel tyrosine kinase inhibitor (TKI) infigratinib for the treatment of different FGFR-driven tumor types, according to Sameek Roychowdhury, MD, PhD, Associate Professor, Medical Oncology, the Ohio State University, Columbus, who presented a poster with the preclinical results at the 2019 American Association for Cancer Research (AACR) meeting.

Atlanta, GA—The investigational PI3K inhibitor umbralisib had encouraging activity as monotherapy in patients with relapsed or refractory marginal-zone lymphoma in an analysis of the phase 2 UNITY-NHL trial. Interim results were presented at the 2019 American Association for Cancer Research (AACR) meeting.

On May 24, 2019, the FDA approved Piqray (alpelisib; Novartis), an oral PIK3 inhibitor, in combination with endocrine therapy with fulvestrant (Faslodex), for the treatment of postmenopausal women, as well as men, with hormone receptor (HR)-positive, HER2-negative advanced or metastatic breast cancer and PIK3CA mutation (as detected by an FDA-approved test) that progressed during or after an ­endocrine-based treatment regimen. The FDA used its priority review designation to consider the application of alpelisib.

On May 3, 2019, the FDA approved a new indication for ado-trastuzumab emtansine (Kadcyla; Genentech) for the adjuvant treatment of patients with HER2-positive early breast cancer who have residual invasive disease after neoadjuvant taxane- and trastuzumab (Herceptin)-based treatment. The FDA granted this application priority review.

On May 2, 2019, the FDA approved ivosidenib (Tibsovo; Agios) for patients with newly diagnosed acute myeloid leukemia (AML) and a susceptible IDH1 mutation, as detected by an FDA-approved test, in patients aged ≥75 years or those who have comorbidities that preclude the use of intensive induction chemotherapy. Ivosidenib was originally approved in 2018 for relapsed or refractory AML with IDH1 mutation.

On April 19, 2019, the FDA accelerated the approval of pembro­lizumab (Keytruda; Merck) plus ­axitinib (Inlyta; Pfizer) as first-line treatment of patients with advanced renal-cell carcinoma (RCC). Keytruda was previously approved as a single agent or in combination with other agents for many other indications and types of cancers.

On April 12, 2019, the FDA accelerated the approval of erdafitinib (Balversa; Janssen), a fibroblast growth factor receptor (FGFR) kinase inhibitor, for the treatment of adults with locally advanced or metastatic urothelial carcinoma and a susceptible FGFR3 or FGFR2 genetic alteration, as detected by an FDA-approved test, whose disease progressed after platinum-containing chemotherapy, making it the first targeted drug to receive approval for this patient population.

Atlanta, GA—Treatment with gilteritinib (Xospata) significantly improved overall survival (OS) with less toxicity compared with chemotherapy in patients with relapsed or refractory acute myeloid leukemia (AML) and FLT3 mutation, according to the final results of ADMIRAL, a phase 3 clinical trial presented at the 2019 American Association for Cancer Research meeting.