Danielle Ternyila

Experts in oncology and hematology review some of the most impactful FDA approvals from 2020 in lung, breast, blood, gastrointestinal, and genitourinary cancers.

Biological activity was observed with dusquetide as treatment of severe oral mucositis in patients with head and neck cancer receiving chemoradiation in the pivotal phase 3 DOM-INNATE study.

The FDA updated the prescribing label for the approval of ibrutinib to include efficacy and safety data as combination therapy with rituximab as treatment of patients with Waldenström’s macroglobulinemia.

The novel CD123-targeting antibody-drug conjugate IMGN632 demonstrated promising clinical activity in a cohort of heavily pretreated patients with relapsed/refractory blastic plasmacytoid dendritic cell neoplasm and had a favorable tolerability.

Encouraging early data were observed with galinpepimut-S in combination with immune checkpoint inhibitors as treatment of patients with 2 different solid tumor types who had exhausted standard therapeutic options.

The submission of a Biologics License Application has been initiated seeking approval of JZP-458 as a part of a multi-agent chemotherapy regimen as treatment of adult and pediatric patients with acute lymphoblastic leukemia or lymphoblastic lymphoma who developed hypersensitivity or silent inactivation to E. coli-derived asparaginases.

Following the 2020 San Antonio Breast Cancer Symposium, Erika P. Hamilton, MD, and William J. Gradishar, MD, shared their key takeaways and insights from the most impactful data presented during this year’s meeting.

The FDA has granted approval to oral relugolix as treatment of patients with advanced prostate cancer.

The FDA granted a Priority Review designation to pembrolizumab for potential approval with platinum and fluoropyrimidine-based chemotherapy as frontline treatment of patients with locally advanced unresectable or metastatic carcinoma of the esophagus and gastroesophageal junction.

Pembrolizumab plus lenvatinib induced a statistically significant and clinically meaningful improvement in overall survival, progression-free survival, and objective response rate compared with chemotherapy in patients with advanced endometrial cancer after prior systemic therapy in the phase 3 KEYNOTE-775/Study 309 trial.

Following the 2020 ASH Annual Meeting, a number of hematology experts shared their insights on the most important data presented during the meeting with Targeted Oncology.

In an interview with Targeted Oncology, Michael J. Wagner, MD, discussed findings from a single-center experience in Seattle managing patients with sarcoma during the COVID-19 pandemic.

The FDA granted a Fast Track designation to devimistat for the treatment of patients with acute myeloid leukemia.

In an interview with Targeted Oncology, Yi Lin, MD, PhD discussed the updated findings from the CRB-401 study of idecabtagene vicleucel as treatment of patients with relapsed/refractory multiple myeloma.

The FDA granted the first Emergency Use Authorization to the vaccine, BNT162b2, for the prevention of COVID-19, which allows for the vaccine to be distributed in the United States for individuals who are at least 16 years or older.

The phase 3 LAURA clinical trial is currently enrolling patients with stage III, unresectable EGFR-mutant non–small cell lung cancer to explore the efficacy and safety of the third-generation tyrosine kinase inhibitor osimertinib as maintenance therapy following chemoradiation.

Only 61% of patients completed therapy fully with checkpoint inhibition as planned, while treatment was delayed or discontinued in 22% due to immune-related adverse events, according to findings from a quality improvement research study conducted by the Association of Community Cancer Centers.

A review of the trending news in oncology online for the week of December 11, 2020, including recent news from the FDA on the cancer treatment paradigm, updates in oncology, and the latest information regarding COVID-19.

In an interview with Targeted Oncology, John M. Burke, MD, discussed the current treatment paradigm for patients with follicular lymphoma and reviewed the factors he considers when making treatment decisions for this population.

No significant differences in recurrence were observed between treatment with tamoxifen or anastrozole in postmenopausal women with locally excised ductal carcinoma in situ.

Despite having similar disease characteristics and treatment patterns, elderly patients with HER2-positive advanced breast cancer aged ≥ 70 years experienced shorter chemotherapy durations than patients under the age of 70, as well as, poorer overall survival, and increased rates of adverse events in a real-world study.

Treatment with higher doses of CPX-351 in younger patients with newly diagnosed high-risk or secondary acute myeloid leukemia was significantly associated with prolonged hematologic recovery times during induction cycles 1 and 2.

The FDA granted a Breakthrough Therapy designation to sotorasib for the treatment of patients with locally advanced or metastatic non–small cell lung cancer who harbored a KRAS G12C mutation following at least 1 prior line of systemic therapy.

Treatment with lorlatinib induced a 72% reduction in the risk of progression or death compared with crizotinib in patients with previously untreated ALK-positive advanced non–small cell lung cancer.

The combination of umbralisib plus ublituximab plus venetoclax demonstrated encouraging efficacy as treatment of patients with relapsed/refractory chronic lymphocytic leukemia, including those who are refractory to prior therapy with a Bruton tyrosine kinase inhibitor.

In an interview with Targeted Oncology, Nirav N. Shah, MD, discussed the findings from the phase 1 study of a CAR T-cell therapy dual targeting CD19 and CD20 as treatment of patients with B-cell lymphomas.

The novel oral cereblon E3 ligase modulator agent CC-92480 in combination with dexamethasone was found to be pharmacologically active with immunomodulatory activity at all doses as treatment of patients with relapsed/refractory multiple myeloma.

Improvements in spleen volume and total symptom score were clinically meaningful with the addition of navitoclax to ruxolitinib in patients with myelofibrosis who no longer benefited from prior ruxolitinib therapy.

A review of the trending news in oncology online for the week of December 4, 2020, including recent news from the FDA on the cancer treatment paradigm, updates in oncology, and the latest information regarding COVID-19.

Enzalutamide achieved both an improvement in progression-free survival and an increase in time to PSA progression compared with bicalutamide as treatment of patients with nonmetastatic castration-resistant prostate cancer.