News

Treatment with AG013 for prevention of oral mucositis did not show statistical significance of severe oral mucositis duration in patients with head and neck cancer undergoing chemoradiation in comparison with placebo, missing the primary end point of the phase II clinical trial, according to early topline results announced in a press release from Oragenics, Inc.

The FDA granted accelerated approval for tucatinib tablets in combination with trastuzumab and capecitabine as treatment of adult patients with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases who have received one or more prior anti-HER2-based regimens in the metastatic setting. The approval comes 4 months ahead of the targeted action date from the FDA’s Real-Time Oncology Review.

In an interview with Targeted Oncology, Andreas Hartkopf, MD, discussed the findings from the RIBECCA trial and the key takeaways from these data for patients with HR-positive HER2-negative breast cancer.

Niraparib was granted Priority Review in China as a maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy, by the National Medical Products Administration.

The FDA has granted approval to the therascreen BRAF V600E Kit as a companion diagnostic to encorafenib, a BRAF inhibitor indicated for the treatment of adult patients with metastatic colorectal cancer harboring a BRAF V600E mutation, as detected by an FDA approved test, in combination with cetuximab after prior therapy.<br /> &nbsp;

The first severe and critically ill patient with coronavirus disease 2019 has been treated with leronlimab in a phase IIb/III clinical trial, announced CytoDyn Inc., developer of the drug. A total of 15 patients have also been enrolled to the phase II trial of patients with mild to moderate COVID-19.

In an interview with Targeted Oncology, H. Jack West, discussed the role telemedicine has taken to support the treatment and post-treatment surveillance of patients with cancer during the COVID-19 pandemic.

Cabozantinib achieved improvements in the progression-free survival, overall survival, and objective response rate in patients with previously treated advanced renal cell carcinoma compared with everolimus, according to data from the phase III METEOR study.

The FDA has granted approval to mitomycin gel as treatment of adult patients with low grade upper track urothelial cancer.

Brain metastasis responses were elicited from treatment with pembrolizumab in patients with non–small cell lung cancer, in a PD-L1–positive cohort of a phase II clinical trial conducted by researchers at Yale Cancer Center. According to a YCC press release, pembrolizumab prolonged overall survival with limited toxicity in these patients.

In an interview with Targeted Oncology, Lipika Goyal, MD, discussed the first- and second-line treatment options for patients with hepatocellular carcinoma and shared her thoughts on how these agents should be sequenced.

A high response rate was demonstrated with the rituximab, bendamustine, and cytarabine regimen as treatment of patients with relapsed or refractory mantle cell lymphoma following treatment with a Bruton tyrosine kinase inhibitor, hinting that the regimen may be an effective bridge to allogeneic stem cell transplantation in patients who are transplant eligible, according to data from a retrospective cohort study.&nbsp;

The CALAVI clinical trial is being initiated to explore the potential of acalabrutinib to treat exaggerated immune response, or cytokine storm, in patients who are severely ill with coronavirus disease 2019, according to a press release from the developer, AstraZeneca.

The FDA has provided clearance to an Investigational New Drug application for GT103 for the treatment of solid tumors. A phase I clinical trial will be initiated to evaluate this novel targeted immunotherapy in patients with refractory non&ndash;small cell lung cancer, announced Grid Therapeutics, LLC.

Protecting the well-being of both patients and healthcare providers remains the prime focus for every institution as the unprecedented coronavirus disease 2019 pandemic evolves rapidly. The Best Practices Committee from the National Comprehensive Cancer Network published recommendations in the Journal of the&nbsp;<a>National Comprehensive Cancer Network</a>&nbsp;for keeping patients with cancer and their healthcare providers safe in response.

The combination of tislelizumab, a PD-L1 antibody, pemetrexed and platinum-based chemotherapy achieved a statistically significant prolongation in progression-free survival compared with pemetrexed and platinum chemotherapy alone as first-line treatment of patients with nonsquamous non&ndash;small cell lung cancer, meeting the primary end point of a phase III BGB-A317-304 trial.

Bortezomib as maintenance therapy following autologous stem cell transplant did not demonstrate a positive effect as treatment of young newly diagnosed patients with mantle cell lymphoma, according to the results of the phase II HOVON trial.

Osimertinib demonstrated statistically significant and clinically meaningful benefit as treatment of patients with stage Ib, II, and IIIA&nbsp;EGFR-mutant non&ndash;small cell lung cancer with complete tumor resection in the phase III ADAURA clinical trial.

In an interview with Targeted Oncology, Nicole Kucine, MD, MS, discussed the findings from her review of the literature on children, adolescents, and young adults with myeloproliferative neoplasms. She highlighted what next steps are needed in this space in terms of research and what a community oncologist should do should for younger patients with myeloproliferative neoplasms.<br /> &nbsp;

An autologous dendritic cell vaccine consisting of autologous dendritic cells loaded with autologous tumor-associated antigens demonstrated&nbsp;promising survival findings in patients with newly diagnosed glioblastoma, according to updated data from a year-end analysis of an ongoing phase II clinical trial.

The FDA has approved selumetinib for the treatment of pediatric patients, aged 2 years and above, with neurofibromatosis type 1 who have symptomatic, inoperable plexiform neurofibromas.

The longest follow-up for ibrutinib monotherapy to date maintained the benefit of the Bruton&rsquo;s tyrosine kinase inhibitor for patients with chronic lymphocytic leukemia/small lymphocytic lymphoma across settings.<br /> &nbsp;

The anti-PD-1 inhibitor camrelizumab showed antitumor activity in pretreated Chinese patients with advanced hepatocellular carcinoma and displayed manageable toxicities, according to a recent paper in Lancet Oncology.

In the epicenter of the coronavirus disease 2019&mdash;Wuhan, China&mdash;a 60-year-old patient with multiple myeloma presented with chest tightness with no fever or cough, in early February. The patient was successfully treated with the anti&ndash;interleukin-6 receptor antibody tocilizumab, according to a case study published in&nbsp;Blood Advances.

Targeted Oncology reviews trending news online for the week of April 10, 2020, including recent updates from studies of COVID-19 and the latest oncology news.

The appropriate gap between diagnosis of chronic lymphocytic leukemia and treatment is now clearer as a new prognostic tool, IPS-E, that can predict the length of &ldquo;watch and wait&rdquo; has been introduced, according to a press release from the American Society of Hematology.

Exposure to ruxolitinib, hydroxyurea, and pipobroman as first-line treatment of Philadelphia-negative myeloproliferative neoplasms alone or in combination with other cytoreductive treatment may increase the probability of patients developing non-melanoma skin cancer, highlighting a need for active dermatological surveillance of these patients, according to findings from the MPN-K study, published in&nbsp;Leukemia.

Treatment with&nbsp;<a>STP705</a>&nbsp;led to the achievement of complete histological clearance of squamous cell carcinoma&nbsp;<em>in situ</em>&nbsp;in a large proportion of patients, meeting the primary end point of the study, according to an interim analysis of the first 3 cohorts in an ongoing phase II clinical trial in patients with non-melanoma skin cancer announced by Sirnaomics Inc.

Blood samples from&nbsp;<a>days 0, 3, and 7</a>&nbsp;demonstrated that leronlimab induced significant reductions in the cytokine storm among all 7 severely ill patients with coronavirus disease 2019 under evaluation in the phase IIb/III study. The blood samples confirmed immunological benefit at day 3 and 7 in all patients, according to a press release from CytoDyn, Inc.

In an interview with&nbsp;Targeted Oncology, Vincent Picozzi, MD, discussed the findings that were presented at the 2020 GI Cancers Symposium for patients with pancreatic cancer and how the results could impact the treatment of this patient population. He also highlighted observations from other pancreatic cancer clinical trials and the evolution of the GI cancer landscape as a whole.&nbsp;