Kristi Rosa

Pirtobrutinib continued to showcase clinically meaningful efficacy in heavily pretreated patients with chronic lymphocytic leukemia or small lymphocytic lymphoma who had prior exposure to a covalent BTK inhibitor.

The addition of atezolizumab to neoadjuvant trastuzumab plus pertuzumab (HP) and chemotherapy led to a numerical, but not statistically significant, increase in pathologic complete response vs HP/chemotherapy alone in patients with HER2-positive operable breast cancer.

The phase 3 KEYLYNK-008 trial evaluating pembrolizumab plus olaparib in patients with metastatic squamous non–small cell lung cancer will be discontinued for futility, according to an announcement from Merck.

The addition of inavolisib to palbociclib and fulvestrant improved progression-free survival vs palbociclib and fulvestrant alone in select patients with PIK3CA-mutated, hormone receptor–positive, HER2-negative, locally advanced or metastatic breast cancer.

The addition of pembrolizumab to neoadjuvant chemotherapy followed by adjuvant pembrolizumab plus endocrine therapy improved pathologic complete responses in key subsets of patients with early-stage, high-risk, estrogen receptor–positive/HER2-negative breast cancer enrolled in the phase 3 KEYNOTE-756 trial.

The FDA has approved iptacopan (Fabhalta) for use in adult patients with paroxysmal nocturnal hemoglobinuria.

The FDA has granted priority review to the supplemental biologics license application seeking the conversion of the accelerated approval of mirvetuximab soravtansine-gynx in patients with FRα-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who previously received 1 to 3 lines of systemic treatment to full approval.

The FDA has granted priority review to a supplemental biologics license application seeking the approval of nivolumab plus cisplatin-based chemotherapy as a frontline treatment option for adult patients with unresectable or metastatic urothelial carcinoma.

The FDA has granted orphan drug designation to LP-284 for use in the treatment of patients with high-grade B-cell lymphoma harboring MYC and BCL2 rearrangements.

The triplet combination of sintilimab, chidamide, and bevacizumab resulted in a high 18-week progression-free survival rate with a favorable toxicity profile in patients with microsatellite stable or mismatch repair–proficient metastatic colorectal cancer, according to data from the phase 2 CAPability-01 trial.

Pembrolizumab continued to demonstrate at trend toward improved overall survival compared with chemotherapy in patients with microsatellite instability–high or mismatch repair–deficient metastatic colorectal cancer.

Perioperative enfortumab vedotin elicited responses in cisplatin-eligible patients with muscle-invasive bladder cancer.

The combination comprised of camrelizumab and famitinib showcased improved efficacy with a manageable safety profile vs camrelizumab monotherapy or investigator’s choice of chemotherapy in patients with recurrent or metastatic cervical cancer.

Nimotuzumab given concurrently with chemoradiotherapy demonstrated efficacy and favorable tolerability in patients with locally advanced cervical squamous cell carcinoma, according to data from a randomized, controlled, open-label, multicenter study.

Retifanlimab-dlwr continued to elicit responses with acceptable tolerability in patients with recurrent microsatellite instability–high or mismatch–repair deficient endometrial cancer, according to final findings from cohort H of the phase 1 POD1UM-101 trial.

The frontline combination of cadonilimab and platinum-based chemotherapy with or without bevacizumab provided a progression-free survival benefit in patients with recurrent or metastatic cervical cancer.

The FDA has approved nirogacestat (Ogsiveo) for adult patients with progressing desmoid tumors who require systemic treatment.

Belantamab mafodotin plus bortezomib and dexamethasone significantly improved progression-free survival compared with daratumumab plus B-Vd in the second-line treatment of patients with relapsed or refractory multiple myeloma, meeting the primary end point of the phase 3 DREAMM-7 trial.

The National Medical Products Administration of China has approved sugemalimab for use in patients with relapsed or refractory extranodal natural killer/T-cell lymphoma.

SCO-101 in combination with leucovorin, fluorouracil, and irinotecan (FOLFIRI) prolonged survival in heavily pretreated patients with metastatic colorectal cancer who had no other active treatment options available, according to final data from part 2 of the phase 2 CORIST study.

MRT-2359 had acceptable tolerability with a favorable pharmacokinetic and pharmacodynamic profile in heavily pretreated patients with MYC-driven solid tumors, including lung cancer and high-grade neuroendocrine cancer.

Volrustomig demonstrated efficacy when used as frontline treatment in patients with clear cell renal cell carcinoma with a toxicity profile that is consistent with dual checkpoint inhibition.

The FDA has approved repotrectinib (Augtyro) for the treatment of adult patients with locally advanced or metastatic ROS1-positive non–small cell lung cancer.

Concurrent administration of durvalumab and platinum-based chemoradiation failed to significantly improve progression-free survival over chemoradiation alone in patients with unresectable stage III non–small cell lung cancer, missing the primary end point of the phase 3 PACIFIC-2 trial.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion supporting the approval of momelotinib for the treatment of disease-related splenomegaly or symptoms in adult patients with moderate to severe anemia with primary myelofibrosis, post–polycythemia vera myelofibrosis, or post–essential thrombocytopenia myelofibrosis who have not been exposed to a JAK inhibitor or who had received prior ruxolitinib.

After a re-examination procedure, the European Medicines Agency’s Committee for Medicinal Products for Human Use has issued a positive opinion on the conditional marketing authorization application for adagrasib in the treatment of adult patients with KRAS G12C–mutated advanced non–small cell lung cancer whose disease progressed following at least 1 prior systemic treatment.

Bayer has announced the intention to voluntarily withdraw the new drug application for copanlisib in adult patients with relapsed follicular lymphoma who have previously received at least 2 prior systemic treatments.

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of pembrolizumab (Keytruda) combined with gemcitabine and cisplatin in the frontline treatment of adult patients with locally advanced unresectable or metastatic biliary tract cancer

The combination of PDS0101, PDS0301 (formerly M-9241), and bintrafusp alfa, an investigational immune checkpoint inhibitor extended survival in patients with advanced human papillomavirus 16–positive cancers, according to final data from a phase 2 trial (NCT04287868) led by the National Cancer Institute.

Durvalumab plus concurrent transarterial chemoembolization followed by durvalumab with bevacizumab resulted in a significant improvement in PFS over TACE alone in patients with hepatocellular carcinoma who are eligible for embolization, meeting the primary end point of the phase 3 EMERALD-1 trial.