Danielle Ternyila

Encouraging anti-tumor activity was observed with the combination of quavonlimab and pembrolizumab when given as frontline therapy to patients with advanced non–small cell lung cancer in a phase 1 study.

Four-year follow-up data from cohort G KEYNOTE-021 reinforced the use of the immune checkpoint inhibitor pembrolizumab in patients with advanced non–small cell lung cancer.

The FDA granted a Priority Review designation to the combination of nivolumab plus cabozantinib for the treatment of patients with advanced renal cell carcinoma.

Two phase 3 clinical trials demonstrated consistent safety findings with the expected safety profile of guadecitabine as treatment of 2 patient populations, including patients with previously treated acute myeloid leukemia in ASTRAL-2 and patients with previously treated myelodysplastic syndrome or chronic myelomonocytic leukemia in ASTRAL-3.

Targeted Oncology reviews trending news online for the week of October 16, 2020, including updates in oncology.

A significant reduction in the risk of death was observed with the addition of sipuleucel-T to either abiraterone acetate or enzalutamide as treatment of patients with metastatic castration-resistant prostate cancer in a real-world analysis.

The primary end point of prolonged progression-free survival in the phase 3 CHRONOS-3 study was met with copanlisib in combination with rituximab as treatment of patients with indolent non-Hodgkin lymphoma.

Uday R. Popat, MD, discusses the role of JAK inhibitors in patients with myeloproliferative neoplasms.

The first CD19/22-directed dual targeting CAR T cell AUTO3 demonstrated a tolerable and best-in-class safety profile as treatment of patients with relapsed/refractory diffuse large B-cell lymphoma.

The FDA granted a Fast Track designation to the novel agent PC14586 for the treatment of patients with locally advanced or metastatic solid tumors that harbor a P53 Y220C mutation.

Tazemetostat as a single agent demonstrated clinically meaningful durable responses as treatment of patients with heavily pretreated relapsed/refractory follicular lymphoma.

In an interview with Targeted Oncology, Rana R. McKay, MD, discussed the findings from the CheckMate-9ER study of nivolumab plus cabozantinib in patients with advanced or metastatic renal cell carcinoma who had not been previously treated.

The FDA has accepted an investigational New Drug application for the investigational CDK2/4/6 inhibitor NUV-422 for the treatment of patients with high-grade gliomas.

A number of targeted agents have been approved in the setting of metastatic breast cancer, which has allowed for more personalized treatment approaches and underscores the importance of genomic testing.

In an interview with Targeted Oncology, Lori J. Wirth, MD, discussed the findings from an analysis of the patient-reported outcomes observed in the LIBRETTO-001 study of selpercatinib in patients with RET-driven thyroid cancers.

Enfortumab vedotin-ejfv induced durable responses as treatment of patients with locally advanced or metastatic urothelial cancer who have previously received immunotherapy but not a prior platinum-containing chemotherapy and are not eligible for cisplatin.

Omidubicel as treatment of patients with high-risk hematologic malignancies induced rapid platelet engraftment and a reduction in the number of infections and hospitalizations, meeting all 3 secondary end points of a phase 3 clinical trial.

During the National Comprehensive Cancer Network 2020 Virtual Congress: Hematologic Malignancies, Aaron Gerds, MD, MS, reviewed the current treatment landscape for patients with myelofibrosis and what’s to come for the treatment of this patient population as clinical trials continue to advance the field.

In an interview with Targeted Oncology, Jens Hillengass, MD, shared his insights on the latest edition of the diagnostic and staging criteria for multiple myeloma that have become standard now for the management of these patients.

Targeted Oncology reviews trending news online for the week of October 9, 2020, including updates in oncology and new information regarding COVID-19.

Obinutuzumab with dexamethasone plus high-dose cytarabine and cisplatin generated good activity for inducing bone marrow minimal residual disease negativity in patients with mantle cell lymphoma who are eligible for transplant.

The FDA issued a draft guidance that encourages the inclusion of premenopausal women with breast cancer in clinical trials, which will in order tohelp researchers determine the efficacy of a hormonal drug or biological products for this population along with others.

In an interview with Targeted Oncology, David J. Pinato, MD, PhD, reviewed how the treatment landscape of hepatocellular carcinoma has evolved over the years and the challenges that clinicians and researchers currently face in the field.

The combination of nivolumab plus chemotherapy induced a statistically significant improvement in pathologic complete response as neoadjuvant treatment of patients with resectable non–small cell lung cancer.

Selpercatinib-related hypersensitivity reactions occurred infrequently in patients with RET fusion-positive non–small cell lung cancer, with more cases reported in patients previously treated with an immune checkpoint inhibitor, but reactions were deemed manageable with recommended guidance and supportive care.

The FDA granted a Breakthrough Therapy designation to IMGN632 as treatment of patients with relapsed or refractory blastic plasmacytoid dendritic cell neoplasms.

Here is a look back at the FDA happenings from the month of September 2020.

Targeted Oncology reviews trending news online for the week of October 2, 2020, including updates in oncology and the latest conference coverage.

The FDA issued a Complete Response Letter to remestemcel-L for the treatment of pediatric patients with steroid-refractory acute-graft-versus-host disease.

In an interview with Targeted Oncology, Anthony P. Conley, MD, discussed findings from an analysis of the efficacy and safety of entrectinib in patients with non-small cell lung cancer harboring a ROS1 or TRK fusion.