News

The FDA has granted a Fast Track designation to CPI-613 for the treatment of metastatic pancreatic cancer.

In an interview with Targeted Oncology, John O. Mascarenhas, MD, discussed the evolving role of JAK inhibitors for the treatment of patients with myelofibrosis, including new agents under evaluation in randomized studies and potential combination strategies that may also improve outcomes.

In an interview with Targeted Oncology, David M. Waterhouse, MD, MPH, discussed the evolving role of genomic testing and related challenges in the lung cancer treatment paradigm as immunotherapies and targeted therapies continue to expand the field.

The FDA expanded approval of FoundationOne® Liquid CDx as a companion diagnostic for olaparib, which is currently indicated for use as treatment in patients with BRCA1/2 and/or ATM alterations in metastatic castration-resistant prostate cancer.

During a debate, Nicholas J. Short, MD, argued that intensive chemotherapy combined with a BCR-ABL tyrosine kinase inhibitor still holds the place of standard-of-care treatment for Phildelphia chromosome acute lymphoblastic leukemia, while Sabina Chiaretti, MD, PhD, made the case for targeted therapy.

Significant short-term disruptions in care delivery were observed during the coronavirus disease 2019 pandemic, which may have long-term consequences in morbidity and survival implications for patients who were unable to receive cancer screening, treatment, and surgery throughout this time.

A review of the trending news in oncology online for the week of November 6, 2020, including recent news from the FDA on the cancer treatment paradigm, updates in oncology, and the latest information regarding COVID-19.

Treatment with neratinib achieved a high percentage of responses in patients with metastatic non–small cell lung cancer patients with EGFR exon 18 mutations who were dosed in a cohort during the interim analysis of the phase 2 SUMMIT basket trial.

In an interview with Targeted Oncology, Caron Jacobson, MD, discussed the data supporting use of CAR T-cell therapy as treatment of patients with diffuse large B-cell lymphoma and some of the remaining questions in this space that need to be addressed as these cellular therapies advanced forward in the field.

A statistically significant increase in the 10-year cumulative incidence of disease progression and definitive treatment among African American men compared with non-Hispanic Caucasian men with low-risk prostate cancer.

Findings from the phase 2 CD10 study of leronlimab as treatment of patients with mild-to-moderate COVID-19 suggest the agent can prevent progression to severe or critical disease.

During a Targeted Oncology Case Based Peer Perspective event, John V. Heymach, MD, PhD, discussed the testing methods for non–small cell lung cancer with MET exon 14 skipping mutations. The discussion was based on the case of a 48-year-old woman.

Selinexor induced a statistically significant reduction in the risk of disease progression or death compared with placebo as treatment of patients with advanced unresectable dedifferentiated liposarcoma.

A broad range of patients with heavily pretreated relapsed/refractory lower-risk myelodysplastic syndrome who were ineligible for treatment with an erythropoiesis-stimulating agent achieved durable red blood cell transfusion independence following treatment with the imetelstat, according to results from the phase 2 IMerge trial.

Based on results from the phase 2 OMNIVORE study, the response-based strategy achieved no complete responses and a low partial response/complete response conversion in advanced renal cell carcinoma.

In an interview with Targeted Oncology, William J. Gradishar, MD, discussed the current treatment options for patients with HER2-positive breast cancer, including the recently approved therapies from the FDA. He also shared his insights on treating patients with brain metastases, in particular.

The FDA lifted a partial clinical hold on the phase 1 P-PSMA-101-001 clinical trial of the chimeric antigen receptor T product P-PSMA-101, which is a potential treatment for patients with metastatic castration-resistant prostate cancer.

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

“In order to make continued progress, one gap we face is the limited diversity in our cohorts of patients in biomedical research.”

A report demonstrated the potential impact of COVID-19 on cancer-related patient encounters, which may result in an increase in the presentation of later-stage disease for newly diagnosed patients in future months.

A draft recommendation statement was published by the United States Preventive Services Task Force stating that screening for colorectal cancer should start at the age of 45, according to a press release from the Task Force Bulletin.

Results of a randomized phase 3 trial demonstrated that the 3-month regimen of adjuvant combination therapy caused significantly less grade 2 or more peripheral sensory neuropathy than the 6-month regimen as treatment of patients with high-risk stage II colorectal cancer, while not affecting the 3-year disease-free survival rate, according to a report in the Annals of Oncology.

In genitourinary cancers, presentation of subgroup analysis data from large randomized clinical trials demonstrated findings that will change practice for oncologists who treat patients with prostate cancer, bladder cancer, and renal cell carcinoma.

The FDA has granted approval to the cobas EGFR Mutation Test v2 as a companion diagnostic for EGFR tyrosine kinase inhibitors as treatment of patients with EGFR-mutant non–small cell lung cancer, which is the first assay approved for this indication.

Targeted Oncology reviews trending news online for the week of October 30, 2020, including recent news from the FDA, updates in oncology, and new information regarding COVID-19.

In an interview with Targeted Oncology, Laurence Albiges, MD, PhD, discussed the updated findings for the combination of nivolumab and ipilimumab as treatment of patients with intermediate- and poor-risk advanced renal cell carcinoma.

While the remarkable activity of crizotinib as treatment of patients with ROS1 fusion-positive advanced non–small cell lung cancer was confirmed in a recent systemic review and meta-analysis, the efficacy of this small molecular inhibitor remains unknown in patients with MET-altered disease.

The FDA has granted an Orphan Drug designation to CPI-613 for the treatment of soft tissue sarcoma.

The FDA has accepted the supplemental Biologics License Application for cemiplimab-rwlc and granted it Priority Review for the frontline treatment of patients with locally advanced or metastatic non–small cell lung cancer with ≥50% PD-L1 expression.

In evaluating MYC rearrangement and its correlation with disease burden and prognostics in newly diagnosed multiple myeloma, a group of Mayo Clinic investigators found that the alteration is associated with high disease burden and independently prognosticates adverse outcomes in patients.