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Chimeric antigen receptor T-cell therapy lead to poor overall survival outcomes it patients who were 75 years or older with relapsed/refractory diffuse large B-cell lymphoma compared with patients aged 70 to 74 years, but progression-free survival was comparable between the 2 groups.

The FDA has granted margetuximab an orphan drug designation for the treatment of patients with gastric and gastroesophageal junction cancer.

Targeted Oncology reviews trending news online for the week of June 5, 2020, including recent news from the FDA, updates in oncology, and new information regarding COVID-19.

In an interview with Targeted Oncology, Aberdeen Mehta, MD, MPH, discussed his experiences practicing palliative care in patients with cancer during the COVID-19 pandemic and how new care plans may continue even after the curve flattens.

Following the 2020 ASCO Virtual Scientific Program, Targeted Oncology spoke with oncologists from various fields to hear their insights on what data they found most impactful in this year’s meeting.

Amivantamab (JNJ-61186372) induced durable responses and demonstrated a manageable safety profile in patients with EGFR exon 20-mutant non–small cell lung cancer (NSCLC), according to results from the phase I CHRYSALIS study (NCT02609776) presented during the 2020 American Society of Clinical Oncology Virtual Scientific Program.

"Selpercatinib had marked intracranial anti-tumor activity in RET fusion–positive patients with [NSCLC and] CNS metastases. Tumor responses were durable, independently confirmed, and observed in patients with prior systemic chemotherapy."

In a subgroup analysis of cohort 1 of the phase 2 ZENITH20 study, patients with previously treated non-small cell lung cancer and EGFR exon 20 insertions demonstrated clinical activity when receiving poziotinib, including those with central nervous system metastatic disease, which was not impacted by prior lines of therapy.

"..These findings may be susceptible to selection bias since patients with more aggressive disease may be more likely to start dabrafenib and trametinib in the first line."

"We believe ropeginterferon alfa-2b could become an important new therapeutic tool and look forward to engaging with the regulators in our efforts to introduce this option to the underserved PV community in the United States."

“Nivolumab monotherapy represents an alternative frontline approach, particularly for the ipilimumab or VEGFR tyrosine kinase inhibitor averse and possible for those with IMDC favorable risk."

In an interview with Targeted Oncology, Sarah C. Rutherford, MD, discussed the phase 1 findings for the combination of venetoclax plus standard chemoimmunotherapy as treatment of patients with aggressive B-cell lymphomas.

Anlotinib appeared safe with a manageable toxicity profile as treatment of patients with recurrent advanced cervical cancer in a phase 2 study.

“With demonstration of efficacy in biomarker-selected BRCA-like phenotype triple-negative breast cancer, the results of this trial are a very positive step toward expanding the role of PARP inhibitors beyond germline BRCA in breast cancer."

MGD013 showed encouraging activity as a single agent as well as in combination with margetuximab as treatment of multiple tumor types in the MDG013 dose-escalation phase 1 study.

"Our data suggests similar activity of infigratinib in patients receiving it in the first-line setting versus subsequent lines for advanced urothelial carcinoma."

A daily dose of osimertinib at 160 mg was well-tolerated with clinical activity observed in patients with EGFR exon 20-mutant non–small cell lung cancer, according to results from the phase 2 ECOG-ACRIN 5162 trial.

Treatment with high-dose osimertinib showed positive survival and central nervous system progressive disease control in a real-world cohort of patients with EGFR-mutant non–small cell lung cancer, but these results were not statistically significant.

Although many of the patients in the study had heavy tumor burden, were in poor physical condition, or had highly aggressive characteristics, they were still able to achieve a satisfactory overall response rate and complete response rate with the tandem CD19/CD20 CAR-engineered T-cell therapy.

Here’s a look back on the FDA happenings from the month of May 2020.

"We are very pleased to announce our pivotal cohort 4 early data from the C-144-01 clinical study in advanced melanoma today."

"The overall response rate and progression-free survival were significantly improved with pyrotinib plus capecitabine."

The autologous anti-CD19 CAR T-cell therapy KTE-X19 had a pharmacodynamic profile associated with efficacy and treatment-related neurological events in patients with relapsed/refractory mantle cell lymphoma, according to data from the ZUMA-2 clinical trial.

"AMG 330 is a CD33 BiTE® molecule under investigation in an ongoing, open-label phase I dose-escalation study and has shown preliminary activity and acceptable safety in relapsed/refractory AML patients."

The FDA has approved ramucirumab in combination with erlotinib for the first-line treatment of patients with metastatic non–small cell lung cancer harboring EGFR exon 19 deletions or exon 21 mutations.

Pembrolizumab should be considered the preferred treatment option and the new standard of care in relapsed/refractory classical Hodgkin's lymphoma in patients that have relapsed post autologous stem cell transplant or are ineligible for autologous stem cell transplant.

Among all the treatment arms in the study, the composite complete response rate was 78% and 100% for those who were treatment-naïve for patients treated with the combination of ivosidenib and venetoclax with or without azacitidine in a phase 1b/2 study.

“For the first-time we have a regimen that markedly improves survival over sorafenib, the standard of care for first-line hepatocellular carcinoma since 2007, and offers patients the opportunity for improved disease control with a favorable tolerability profile.”

In an interview with Targeted Oncology, Ursula A. Matulonis, MD, discussed the findings from a TWiST analysis of the ENGOT-OV16/NOVA study, which evaluated the time without symptoms or toxicities in patients with recurrent ovarian cancer who received niraparib as maintenance.

“[The study confirmed] that use of Immunoscore® in combination with established prognostic factors allows one to more accurately assess prognosis, highlighting the clinical utility of Immunoscore."