Kristi Rosa

December 10, 2020 — The addition of ribociclib to endocrine therapy continued to significantly improve overall survival and delay subsequent chemotherapy compared with placebo, irrespective of endocrine partner in patients with hormone receptor–positive, HER2-negative breast cancer.

December 9, 2020 - Follow-up circulating tumor cell assessments were confirmed to strongly predict overall survival outcomes in patients with metastatic breast cancer, when performed at a median of 29 days following treatment initiation.

The antibody-drug conjugate TRPH-222 demonstrated early signs of efficacy with favorable tolerability at higher dose levels in patients with relapsed/refractory B-cell non-Hodgkin lymphoma.

December 8, 2020 - The FDA has granted a breakthrough therapy designation to sotorasib for use as a potential treatment in patients with KRAS G12C–mutated locally advanced or metastatic non–small cell lung cancer.

December 7, 2020 - The addition of ixazomib to lenalidomide and dexamethasone resulted in a clinically meaningful 13.5-month improvement in the median progression-free survival of elderly patients with transplant-ineligible newly diagnosed multiple myeloma, although it did not reach statistical significance.

Treatment with the BCMA-targeted CAR T-cell therapy idecabtagene vicleucel was found to yield clinically meaningful improvements in the quality-of-life of triple-class exposed patients with relapsed/refractory multiple myeloma.

December 6, 2020 - The first-of-its-kind FcRH5xCD3 bispecific antibody cevostamab demonstrated a manageable safety profile with an overall response rate of 53% in heavily pretreated patients with relapsed/refractory multiple myeloma who received active doses.

December 6, 2020 — The off-the-shelf DuoBody® IgG4 PAA binding antibody talquetamab has elicited a high response rate with a tolerable safety profile in heavily pretreated patients with relapsed/refractory multiple myeloma.

December 6, 2020 — Patients with hematologic malignancies are at increased risk for significant morbidity and mortality from coronavirus disease 2019, and the risk of death appeared to be greatest in those who were older, had more severe infection, a poorer prognosis, or who decided to forego intensive treatment

A novel combination comprised of the oral, selective RARα agonist SY-1425 and azacitidine demonstrated clinical activity with acceptable tolerability in a heavily pretreated population of patients with relapsed/refractory acute myeloid leukemia with RARA positivity.

December 5, 2020 - Ruxolitinib was found to elicit a significantly higher overall response rate, a substantially greater improvement in failure-free survival, and greater symptom improvement versus best available therapy in patients with chronic graft-versus-host disease with an inadequate response to corticosteroids.

December 4, 2020 - The completion of the biologics license application for balstilimab in the treatment of patients with recurrent or metastatic cervical cancer has been delayed to the first half of 2021.

December 3, 2020 — The survivin-targeted T-cell therapy DPX-Survivac, when used in combination with intermittent low-dose cyclophosphamide, prolonged clinical benefit with promising tolerability in patients with recurrent, advanced platinum-sensitive and -resistant ovarian cancer.

December 3, 2020 - Lurbinectedin plus doxorubicin failed to significantly improve overall survival versus physician’s choice of topotecan or cyclophosphamide/doxorubicin/vincristine in patients with small cell lung cancer who progressed after 1 previous platinum-containing line of treatment, missing the primary end point of the phase 3 ATLANTIS trial.

December 3, 2020 — A biologics license application has been submitted to the FDA for the EGFR-MET bispecific antibody amivantamab for the treatment of patients with metastatic non–small cell lung cancer with EGFR exon 20 insertion mutations who have progressed on or following a platinum-based chemotherapy.

December 2, 2020 - Patients with high-grade Bacillus Calmette-Guérin unresponsive non-muscle invasive bladder cancer who responded to the investigational gene therapy nadofaragene firadenovec had a lower rate of cystectomy and delayed time to cystectomy compared with those who did not respond.

December 1, 2020 - The FDA has approved pralsetinib for the treatment of select patients with advanced or metastatic RET-mutant medullary thyroid cancer who require systemic therapy or RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory.

December 1, 2020 - The FDA has approved Gallium 68 PSMA-11, the first drug for PET imaging of prostate-specific membrane antigen–positive lesions in patients with prostate cancer.

December 1, 2020 — The FDA has granted a fast track designation to irinotecan liposome injection as second-line monotherapy option for patients with small cell lung cancer whose disease progressed following a platinum-based chemotherapy regimen.

December 1, 2020 - A rolling submission of a biologics license application to the FDA has been initiated for the CD20-directed monoclonal antibody ublituximab in combination with the PI3K-delta and CK1-epsilon inhibitor umbralisib for the treatment of patients with chronic lymphocytic leukemia.

December 1, 2020 - The FDA has granted a priority review designation to the oral FGFR1-3 selective inhibitor infigratinib for the treatment of patients with cholangiocarcinoma.

November 24, 2020 - Pexidartinib was found to result in prolonged efficacy with favorable safety in patients with tenosynovial giant cell tumors, according to long-term data from a pooled analysis of 3 cohorts of patients who received the agent.

November 23, 2020 - Yelena Y. Janjigian, MD, discusses future research efforts are focused on examining anti–PD-1 combination strategies, particularly with HER2-directed therapies.

November 23, 2020 - The China National Medical Products Administration has approved denosumab for the prevention of skeletal-related events in patients with bone metastases from solid tumors and in those with multiple myeloma.

November 23, 2020 - Ripretinib demonstrated clinically meaningful activity in patients with fourth-line or later advanced gastrointestinal stromal tumor and several, heterogeneous genetic subsets of KIT/PDGFRA mutations.

November 21, 2020 - Frontline sintilimab injection in combination with bevacizumab biosimilar injection resulted in a significant improvement in overall survival and progression-free survival per Independent Radiographic Review Committee versus sorafenib in patients with advanced unresectable hepatocellular carcinoma.

November 20, 2020 - Patients from Asian countries with hormone receptor–positive, HER2-negative breast cancer may have a higher risk of disease recurrence than those from non-Asian countries, suggesting that this population may benefit from additional adjuvant treatment with abemaciclib.

November 20, 2020 - The FDA has granted a priority review designation to a biologics license application for loncastuximab tesirine for the treatment of patients with relapsed or refractory diffuse large B-cell lymphoma.

November 20, 2020 - The FDA has approved durvalumab for an additional dosing option, a fixed dose of 1500 mg every 4 weeks, in the approved indications of unresectable stage III non-small cell lung cancer after chemoradiation and previously treated advanced bladder cancer.

November 19, 2020 - A computational method comprised of clinicodemographic variables with deep learning of pretreatment histology images may be able to effectively predict response to immunotherapy in patients with advanced melanoma.