News

In the epicenter of the coronavirus disease 2019—Wuhan, China—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–interleukin-6 receptor antibody tocilizumab, according to a case study published in 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 “watch and wait” 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 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;

A Biologics License Application for avelumab, a PD-L1 inhibitor, was submitted to the FDA for consideration as first-line treatment of patients with locally advanced or metastatic urothelial cancer and the agent was granted Breakthrough Therapy Designation, announced Merck KGaA, in a press release.<br /> &nbsp;

The FDA has approved the combination of encorafenib and cetuximab as treatment of patients with metastatic colorectal cancer with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy, according to a press release from Pfizer.&nbsp;

The addition of pemetrexed and carboplatin chemotherapy to gefitinib doubled progression-free survival and significantly improved overall survival in patients with non&ndash;small cell lung cancer harboring an&nbsp;EGFR&nbsp;mutation compared with gefitinib alone, according to results from a randomized phase III clinical&nbsp;<a>trial</a>.

Paxalisib had a strong signal of clinical efficacy in patients with newly diagnosed glioblastoma, according to the interim analysis of a phase II clinical trial. Survival was compared to previous data on the FDA-approved standard of care, temozolomide, from another study. Although the comparison of different studies is not precise, the magnitude of numerical difference in survival provides evidence that this agent may extend life in patients with glioblastoma, Kazia Therapeutics announced in a press release.&nbsp;

Icotinib, an EGFR tyrosine kinase inhibitor, demonstrated similar efficacy to gefitinib as a treatment of brain metastasis in patients with EGFR-mutated non&ndash;small cell lung cancer, results from a Chinese retrospective study showed.

The FDA has accepted the Biologics License Application for and granted Priority Review to the combination of nivolumab plus ipilimumab with limited chemotherapy as a first-line treatment of patients with metastatic or recurrent non&ndash;small cell lung cancer who have no&nbsp;EGFR&nbsp;or&nbsp;ALK&nbsp;genomic tumor aberrations, according to a press release from Bristol Myers Squibb. The Prescription Drug Free User Act target action date is set as August 6, 2020, and the combination was granted Fast Track designation.

In an interview with Targeted Oncology, James A. Reeves, MD, discussed how targeted therapies are being used presently in lung cancer and the potential of these agents in the future.

Low-dose selinexor will be evaluated in a global randomized clinical trial for hospitalized patients with severe coronavirus disease 2019. This oral selective inhibitor has previously been approved at higher doses by the FDA for the treatment of patients with relapsed/refractory multiple myeloma. The plans to initiate this clinical trial were announced in a press release from Karyopharm Therapeutics Inc, developer of the drug.

Indigenous American ancestry has been linked to an increased incidence of HER2-positive breast cancer, according to the Peruvian Genetics and Genomics of Breast Cancer Study study published in Cancer Research.

The FDA has granted Fast Track designation to balstilimab, an investigational anti-PD-1 agent for the treatment of patients with cervical cancer, based on comprehensive data that suggest balstilimab can fill an unmet medical need in the space, Agenus, Inc announced in a press release. In light of the new designation, the company now plans to submit 2 Biologic License Applications in 2020, for this indication and the other for the combination of balstilimab and zalifrelimab&nbsp;in metastatic cervical cancer.

Sacituzumab govitecan was granted Fast Track designation by the FDA for the treatment of patients with locally advanced or metastatic urothelial cancer who have previously received a programmed death receptor-1 or programmed death-ligand 1 inhibitor, and a platinum-containing chemotherapy in the neoadjuvant/adjuvant, including patients who are platinum ineligible.

A single-institution study from Wuhan, Hubei, showed that admission or recurrent visits to the hospital put patients with cancer at risk for severe adult respiratory syndrome coronavirus 2 infection, and patients with non&ndash;small cell lung cancer over the age of 60 had a higher incidence of coronavirus disease 2019.

In an interview with&nbsp;Targeted Oncology, Maria Reig, MD, PhD, discussed the results from the retrospective analysis of patients with hepatocellular carcinoma treated with nivolumab in the real-life setting in Spain.

The FDA has accepted and granted a priority review to a supplemental Biologics License Application for pembrolizumab for the treatment of adult and pediatric patients with unresectable or metastatic solid tumors with tissue tumor mutational burden-high who have progressed following prior treatment and who have no satisfactory alternative treatment options.

Treatment with sacituzumab govitecan resulted in &ldquo;compelling evidence of efficacy&rdquo; in patients with metastatic triple-negative breast cancer, leading to an early halt of the phase III ASCENT study, announced Immunomedics in a press release.

Pembrolizumab demonstrated an improvement in progression-free survival in the first-line treatment of patients with microsatellite instability-high or mismatch repair deficient unresectable or metastatic colorectal cancer, meeting one of the primary end points of the phase III KEYNOTE-177 trial.

The first liquid biopsy assay, a blood test, to detect over 50 types of cancer has been developed and is able to identify in which part of the body that the cancer originated in, based on findings from a prospective multicenter case-control observational trial, the CCGA study published in&nbsp;Annals of Oncology.&nbsp;The test also identified cancer prior to symptoms in most patients, according to a press release.

In an interview with&nbsp;Targeted Oncology, Richard D. Carvajal, MD, discussed the challenges of conducting clinical trials for the treatment of patients with uveal melanoma, as well as the excitement surrounding 2 potential therapies in this space.

The FDA granted approval to luspatercept-aamt as treatment of adult patients with anemia failing an erythropoiesis stimulating agent that requires 2 or more red blood cell units over 8 weeks, that is associated with very low- to intermediate-risk myelodysplastic syndromes,&nbsp;intermediate-risk myelodysplastic syndromes with ring sideroblasts or myelodysplastic/myeloproliferative neoplasm.

Targeted Oncology reviews trending news and videos online for the week of April 3, 2020, including recent updates on the impact of COVID-19 in oncology practice and other FDA news.

Durable remissions were elicited with KTE-X19 in a majority of patients with relapsed or refractory mantle cell lymphoma, according to the updated results from the ZUMA-2 trial published in the New England Journal of Medicine. The treatment did, however, cause serious adverse events that were consistent with known toxicities of chimeric antigen receptor T-cell therapy.

A phase III trial is being planned to explore the use of ruxolitinib (Jakafi) to treat patients with coronavirus disease 2019&ndash;related cytokine storm, according to a press release from Incyte regarding discussions with the FDA.

Despite unprecedented challenges during the month of March 2020 due to the coronavirus disease 2019 pandemic, the FDA continued to push forward with several new approved indications for the treatment of cancer, as well as other designations that could further advance the treatment landscape.