Danielle Ternyila

“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.

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.

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.

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."

"This designation is a significant validation of not only our onvansertib clinical program, which is now eligible for priority review and accelerated approval, but it also signifies recognition of the medical need for new effective treatment options.”

"Since submitting the BLA for margetuximab, we have worked collaboratively with the FDA to answer the Agency’s questions as they arise. We will continue to work closely with the Agency to potentially bring margetuximab as a treatment option to patients with HER2-positive metastatic breast cancer."

In an interview with Targeted Oncology, Maria E. Cabanillas, MD, discussed the findings from a clinical trial evaluating potential atezolizumab combinations in patients with anaplastic thyroid cancer.

The immune checkpoint inhibitor induced 1 objective response but appeared safe as treatment of patients with metastatic high-grade neuroendocrine neoplasms in 2 open-label phase 2 clinical trials.

Targeted Oncology reviews trending news online for the week of May 22, 2020, including recent news from the FDA, updates in oncology, and new information regarding COVID-19.

The FDA has granted approval to brigatinib for the frontline treatment of patients with ALK-positive metastatic non–small cell lung cancer, as detected by an FDA-approved test.

Fam-trastuzumab deruxtecan-nxki has received an Orphan Drug designation for the treatment of patients with gastric or gastroesophageal junction cancer.

In an interview with Targeted Oncology, Lajos Pusztai, MD, DPhil, discussed the findings from the phase I/II clinical trial of durvalumab in combination with concurrent nab-paclitaxel and doxorubicin plus cyclophosphamide in the neoadjuvant setting for patients with triple-negative breast cancer.

In an interview with Targeted Oncology, following a tweet chat on prostate cancer, Tian Zhang, MD, discussed the key takeaways from the tweet chat discussion and highlighted both the role of molecular testing and the impact of the recent FDA approvals in prostate cancer.

In an interview with Targeted Oncology, Robert L. Coleman, MD, FACOG, FACS, discussed the importance of molecular testing in ovarian cancer and how the treatment landscape will continue to evolve in tailoring treatment to patients based on the biology of their tumors, which was the topic of his lecture at the 2020 Society for Gynecologic Oncology (SGO) Annual Meeting.

“In this study, we evaluated ruxolitinib as a bridge, relapse, and GVHD prevention agent in patients with myelofibrosis. The regimen was well tolerated, with an acceptable rate of organ toxicity."

“This randomized phase III study for the first time provides prospective long-term results on survival and other end points of interest after standard treatment with CHOP in patients with PTCL beyond 60 years who represent the majority of [patients with] PTCL, generally less eligible for more intense therapies like autologous and allogeneic transplantation."

"Promising results would pave the way to a larger clinical trial that would include non-cancer patients at high risk for COVID-19 complications.”

“Although PARP inhibitor treatment has demonstrated radiographic and PSA responses in patients with BRCA alterations (4–8), the data presented here offer compelling evidence that response to PARP inhibitors is limited in men with mCRPC harboring an ATM, CDK1/2, or CHEK2 alteration."

In an interview with Targeted Oncology, Peter Schmid, MD, PhD, discussed the findings from the interim analysis for the phase III KEYNOTE-522 study, which added pembrolizumab to neoadjuvant chemotherapy in patients with early-stage triple-negative breast cancer.

In an interview with Targeted Oncology, Steve A. Soper, PhD, discussed microfluidic platforms for use in isolating circulating leukemia cells and plasma cells in patients with acute lymphoblastic leukemia and acute myeloid leukemia.

“This study is 1 of the first [to report on a] chemoimmunotherapy combination in the second- and third-line setting of metastatic urothelial carcinoma."

"Today’s approval of Qinlock establishes a new standard of care for patients who have received three prior therapies."

Targeted Oncology reviews trending news online for the week of May 15, 2020, including recent updates from studies of COVID-19 and the latest oncology news.

“Our results raise a number of questions for future research and patient care. It will be important in future studies to explore whether lowering insulin levels or targeting IR signaling will improve breast cancer disparities."