Chris Ryan

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of Lutetium 177 vipivotide tetraxetan in combination with androgen deprivation therapy with or without androgen receptor pathway inhibition for the treatment of adult patients with progressive prostate-specific membrane antigen–positive metastatic castration-resistant prostate cancer who have been treated with AR pathway inhibition and taxane-based chemotherapy.

Treatment with mirvetuximab soravtansine elicited a statistically significant benefit vs investigator’s choice of chemotherapy for the OV28 abdominal/gastrointestinal symptom subscale in patients with folate receptor alpha–positive, advanced ovarian cancer.

Representatives from Elevar Therapeutics and the FDA held a positive pre–new drug application meeting to discuss the combination of rivoceranib and camrelizumab as a potential therapeutic option for patients with hepatocellular carcinoma.

Zanubrutinib produced a superior progression-free survival benefit compared with ibrutinib in previously treated patients with relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma, according to the final PFS analysis of the phase 3 ALPINE trial.

The combination of TQB2450 plus anlotinib generated responses and showcased a manageable safety profile in patients with recurrent or metastatic advanced endometrial cancer, according to data from the phase 2 TQB2450 II 08 trial.

The FDA has accepted and granted priority review to a supplemental biologics license application for sacituzumab govitecan for the treatment of with unresectable locally advanced or metastatic hormone receptor–positive, HER2-negative breast cancer after endocrine-based therapy and at least 2 additional systemic therapies in the metastatic setting.

The combination of nivolumab and ipilimumab (Yervoy) was associated with worse clinical benefit in patients with metastatic clear cell renal cell carcinoma who have low serum iron compared with patients with normal/high serum iron.

The combination of pegylated liposomal doxorubicin, cyclophosphamide, trastuzumab, and pertuzumab elicited encouraging responses with acceptable safety when given as neoadjuvant treatment in patients with HER2-positive breast cancer.

An independent data monitoring committee has recommended that the phase 2 ENVASARC trial examining envafolimab with and without ipilimumab in patients with undifferentiated pleomorphic sarcoma and myxofibrosarcoma continue as planned.

DZD1516 monotherapy elicited early clinical activity and was found to be well tolerated in patients with HER2-positive metastatic breast cancer with or without brain metastases.

The FDA has granted a fast track designation to eftilagimod alpha for use in combination with pembrolizumab as a frontline treatment for patients with stage IIIB/IV non–small cell lung cancer.

The FDA has agreed on key elements of the clinical program to support the biologic license application for the combination of PDS0101 and pembrolizumab for the treatment of unresectable, recurrent/metastatic HPV16-positive head and neck squamous cell carcinoma.

The addition of talazoparib to enzalutamide produced a statistically significant and clinically meaningful improvement in radiographic progression-free survival vs enzalutamide plus placebo in previously untreated patients with metastatic castration-resistant prostate cancer, with or without homologous recombination repair gene mutations.

Single-agent rucaparib significantly improved radiographic progression-free survival vs chemotherapy or second-line androgen deprivation therapy in chemotherapy-naïve patients with metastatic castration-resistant prostate cancer harboring BRCA or ATM mutations.

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.