News

The review of the Biologics License Application for idecabtagene vicleucel has been put on hold. The FDA issued a Refusal to File letter due to the need for additional data from the developer of the drug.

"Targeting PD-1/PD-L1 may provide a much-needed treatment option for patients with PDL1–positive advanced ATC."

In an interview with Targeted Oncology, Scott Haake, MD, discussed the current understandings of SETD2 mutations in clear cell renal cell carcinoma and the findings presented at the 2019 International Kidney Cancer Symposium.

“Our study demonstrates that venetoclax is a potential salvage therapy in multiply relapsed patients with MCL. The majority (92%) patients in this study were exposed to BTKi, 66% were BTKi refractory, and these patients exhibited poor outcomes."

"These results have the potential to substantially move the field forward and represent an important step toward making stem cell transplantation more accessible and more successful for patients with lethal blood cancers. Shortening the time to engraftment is clinically meaningful, as it can reduce a patient’s time in the hospital and decrease likelihood of infection."

"This is the second positive phase 3 trial for Sarclisa, further supporting the potential our medicine has to improve outcomes for patients struggling with relapsed multiple myeloma.”

“We’ve had to quickly shift gears and adapt to a new COVID-19 world. Our practices have taken every possible step to continue providing quality cancer care, safely. Because cancer does not stop for even a global pandemic, and neither does the need of cancer patients to get treated.”

In an interview with Targeted Oncology, Erica Mayer, MD, discussed advances in the treatment landscape of HR-positive, HER2-negative breast, primarily with endocrine therapy and CDK4/6 inhibition.

"Current guidelines for the management of nausea and vomiting in patients with advanced cancer have not specifically indicated that one drug looks substantially better than a variety of other drugs. However, we believe the present results may be viewed as a best practice for treating nausea and vomiting in patients with advanced cancer-associated nausea and vomiting."

In an interview with Targeted Oncology, Toni K. Choueiri, MD, discussed the findings from the phase I/II study of the oral HIF-2 α inhibitor MK-6482 in patients with advanced clear cell RCC, which were presented at the 2020 Genitourinary Cancers Symposium.

Trastuzumab deruxtecan received Breakthrough Therapy Designation for the treatment of patients with HER2-positive unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma who have received two or more prior regimens including trastuzumab.

Patients with relapsed or refractory chronic lymphocytic leukemia who received a higher dose of CAR T cells, achieved complete responses, regardless of cell dose, which was highly correlated with long-term survival.

The FDA has approved selpercatinib capsules for the treatment of patients with lung cancer or thyroid cancer harboring RET alterations. This marks the first treatment approved to target RET gene alterations.

"HER2-targeted therapy has changed the natural history of HER2-positive metastatic breast cancer, with the dual blockade of pertuzumab and trastuzumab, with docetaxel, demonstrating an 8-year landmark overall survival rate of 37%."

Targeted Oncology reviews trending news online for the week of May 8, 2020, including recent updates from studies of COVID-19 and the latest oncology news.

To disseminate results that can inform the public health in response to COVID-19, CytoDyn announced the publication of their findings in a pre-print manuscript, which has been submitted for publication and is currently under peer review.

"Combining pembrolizumab with Tavo electroporation improved responses for these patients who were predicted to have very poor responses to single-agent immune checkpoint inhibition."

The FDA granted approval to the combination of olaparib and bevacizumab for the maintenance treatment of patients with advanced ovarian cancer who are in complete or partial response to first-line platinum-based chemotherapy with bevacizumab and whose cancer is associated with homologous recombination deficiency–positive status defined by either a deleterious or suspected deleterious BRCA mutation, and/or genomic instability.

In an interview with Targeted Oncology, David Ritchie, MD, PhD, discussed the findings from the substudy of the AIM clinical trial, which evaluated the combination of venetoclax and ibrutinib in patients with MCL.

"We are very excited to have received the RMAT designation for ilixadencel in kidney cancer as it recognizes both the potential of our novel therapeutic approach as well as the clear need for viable therapies to address this difficult-to-treat disease."

"This simultaneous therapy and companion diagnostic approval marks an important step forward in the treatment of rare cancer and demonstrates how deep collaboration across industry partners can advance patient care.”

In an interview with Targeted Oncology, Nikhil C. Munshi, MD, discussed the rationale for evaluating NKTR-255 as treatment of patients with multiple myeloma.

Administering endoxifen in the window of opportunity between diagnosis and treatment may be effective for reducing tumor activity in patients with breast cancer.

Based on these findings, the 200 mg dose of canakinumab administered subcutaneously every 3 weeks in combination with the standard dose of pembrolizumab and a platinum-based chemotherapy doublet will be used in the next phase of the CANOPY-1 study.

"The emergence of the anti-PD-1 antibody has brought a new treatment modality for patients with squamous NSCLC."

In an interview with Targeted Oncology, Lori A. Leslie, MD, discussed the importance of analyzing treatment outcomes in real-world patients with chronic lymphocytic leukemia compared with only reviewing data from clinical trials that do not represent all patients seen in the community setting.

“We are pleased that the FDA has approved Tabrecta for patients with METex14 NSCLC. Having a therapy that targets the recognized oncogenic driver will provide a much needed treatment option for patients with METex14 NSCLC who currently have limited treatment options.”

“To the best of our knowledge, this is the first report about obinutuzumab and venetoclax induced CR in a rituximab-intolerant patient with an ibrutinib-resistant leukemic MCL."

"Mesothelioma remains a challenging disease with generally poor prognosis, and there is a large unmet medical need for new, innovative treatments such as ONCOS-102..."

"Having obtained an encouraging proof-of-concept for the liver-cancer directed effect of MIV-818 in phase Ia, we hope to get additional supportive data from the phase Ib study. We believe that MIV-818 has the potential to provide liver cancer patients with major therapeutic benefits."