News

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."

The FDA extended the Prescription Drug User Fee Act target action date for liso-cel due to the submission of additional information by the drug developer, which will require additional time to review.

“While these findings cannot be exploited to improve clinical decision making today, our results, and the underlying data, collected on an increasingly rare group of triple-negative breast cancer patients treated with locoregional therapy alone, are a valuable contribution to ongoing research on the development, progression and ultimate treatment of triple-negative breast cancer."

"It’s extremely gratifying to see positive results for this important trial exploring the combination of umbralisib and ublituximab in patients with both front-line and relapsed/refractory CLL."

The study results indicated clinical efficacy against central nervous system metastases in a cohort of patients. Almonertinib also displayed an overall favorable safety profile.

Results from the phase Ib/II study of VERU-111 in patients with metastatic castration-resistant prostate cancer have prompted plans to meet with the FDA in the third quarter of 2020 to discuss the trial design for a phase III clinical trial of VERU-111 for this indication.

"...These important new results further demonstrate Libtayo’s potential in patients with difficult-to-treat, non-melanoma skin cancers."

“We are excited to partner with AON to continue to bring the same level of patient care and compassion coupled with access to additional services that will benefit our patients."

A safety, tolerability, pharmacokinetics, and preliminary efficacy of avadomide in patients with advanced solid tumors, non-Hodgkin lymphomas, or multiple myeloma shows evidence of preliminary activity. Findings from the diffuse large B-cell cohort were published in Blood.

A new phase II trial showed higher pathological complete response rates in patients with HER2-positive breast cancer who took docetaxel, carboplatin, trastuzumab, and pertuzumab followed by trastuzumab emtansine, and pertuzumab, versus those who took only the former therapy.

“This combined genomic and epigenomic plasma-based ctDNA test continues to demonstrate high sensitivity and specificity which significant implications for its clinical utility of CRC detection,”

There is a significant unmet clinical need [for] treatment of CML globally. This Orphan Drug Designation from FDA marks a major milestone for HQP1351..."

In an interview with Targeted Oncology, Bruce L. Levine, PhD, discussed hot topics in the treatment landscape of melanoma, including the development of chimeric antigen receptor T and NK cells.