Chris Ryan

The FDA has granted an orphan drug designation to SynKIR-110, a first-in-class KIR-CAR T-cell immunotherapy candidate, for the treatment of patients with mesothelin-expressing mesothelioma.

The FDA has granted a fast track designation to AL102 for the treatment of patients with progressing desmoid tumors.

The Japan Ministry of Health, Labor and Welfare has approved valemetostat tosilate for the treatment of patients with relapsed or refractory adult T-cell leukemia/lymphoma.

The FDA has granted a fast track designation to ficlatuzumab for the treatment of patients with relapsed or recurrent head and neck squamous cell carcinoma.

Maintenance treatment with rituximab following first-line treatment with rituximab plus bendamustine or rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone produced an overall survival benefit in older patients with mantle cell lymphoma.

Single-agent dostarlimab showcased durable antitumor activity in patients with mismatch repair–deficient endometrial cancer and other solid tumors, with landmark estimates at various time points underscoring stable progression-free survival benefits in responders.

Olaparib plus bevacizumab was approved in China as a first-line maintenance treatment for homologous recombination deficiency–positive ovarian cancer following a response to platinum-based chemotherapy plus bevacizumab.

The BCMA-directed CAR T-cell therapy zevorcabtagene autoleucel demonstrated a 100% objective response rate in heavily pretreated patients with relapsed/refractory multiple myeloma

The combination of fianlimab and cemiplimab demonstrated clinically meaningful activity in patients with advanced melanoma who were naïve to anti–PD-1/PD-L1 therapy.

Treatment with immunotherapy prior to the development of brain metastases improved the median overall survival in patients with metastatic renal cell carcinoma.

Treatment with soluble EphB4-human serum albumin plus pembrolizumab elicited synergistic activity and an improved overall survival and objective response rate compared with historical data for PD-1/PD-L1 monotherapy in patients with platinum-refractory metastatic urothelial carcinoma.

The European Medicines Agency Committee for Medicinal Products for Human Use has granted a positive opinion for axicabtagene ciloleucel for the treatment of adult patients with diffuse large B-cell lymphoma and high-grade B-cell lymphoma who relapse within 12 months from completion of, or are refractory to, first-line chemoimmunotherapy.

The European Medicines Agency Committee for Orphan Medical Products has granted an orphan drug designation to CAN-2409 for the treatment of patients with glioma.

The ROR1-targeting bispecific T-cell engager NVG-111 elicited promising responses with a manageable safety profile in patients with relapsed/refractory chronic lymphocytic leukemia or mantle cell lymphoma.

The decline of prostate-specific antigen following treatment with lutetium Lu 177 vipivotide tetraxetan plus standard of care was linked with prolonged radiographic progression-free survival and overall survival in patients with progressive prostate-specific membrane antigen–positive metastatic castration-resistant prostate cancer.

The FDA has granted an orphan drug designation to DUNP19 for the treatment of osteosarcoma.

Adagrasib monotherapy and in combination with cetuximab generated encouraging responses in patients with advanced colorectal cancer harboring KRAS G12C mutations.

A tailored approach utilizing the combination of nivolumab and ipilimumab as an immunotherapeutic boost following induction with single-agent nivolumab improved responses in the first and second line for patients with advanced renal cell carcinoma.

Single-agent lasofoxifene did not produce a statistically significant improvement in progression-free survival vs fulvestrant for patients with estrogen receptor–positive, HER2-negative metastatic breast cancer harboring ESR1 mutations.

The FDA has approved eflapegrastim-xnst injection to decrease the incidence of infection, as manifested by febrile neutropenia, in adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia.

Adding oleclumab to durvalumab and chemotherapy did not increase the clinical benefit rate vs durvalumab plus chemotherapy alone as a first-line treatment for patients with advanced triple-negative breast cancer.

Saul A. Rosenberg, MD, FASCO, the Maureen Lyles D’Ambrogio Professor Emeritus at Stanford School of Medicine and the 2019 Giants of Cancer Care® award winner for Lymphoma, died at the age of 95.

The FDA has granted fast track designation to AMB-05X for the treatment of patients with tenosynovial giant cell tumors.

Second-line treatment with ramucirumab produced an overall survival benefit vs placebo in Chinese patients with hepatocellular carcinoma, irrespective of the presence of extrahepatic spread, according to findings from an exploratory analysis of the phase 3 REACH and REACH-2 trials.

The FDA has approved the biosimilar pegfilgrastim for use in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.

First-line treatment with pivekimab sunirine generated responses with favorable tolerability in patients with blastic plasmacytoid dendritic cell neoplasm, according to data from the phase 2 CADENZA trial.

The addition of vopratelimab to pimivalimab did not elicit a significant mean percent change of baseline tumor size in all measurable lesions vs pimivalimab alone in patients with immunotherapy-naïve, metastatic non–small cell lung cancer who were positive for the TISvopra predictive biomarker.

Sotorasib demonstrated superiority and a statistically significant benefit in progression-free survival vs standard-of-care docetaxel in previously treated patients with KRAS G12C–mutated non–small cell lung cancer.

The combination of gefitinib plus chemotherapy generated a benefit in time to second progression vs gefitinib alone in untreated patients with EGFR-mutated non–small cell lung cancer.

The FDA has granted permission for enrollment to resume in the monotherapy phase 1a portion of the phase 1/2 TakeAim Leukemia trial evaluating emavusertib in relapsed/refractory acute myeloid leukemia or high-risk myelodysplastic syndromes.