Global Bulletin

The CheckMate 9DW trial found that nivolumab and ipilimumab elicited a median OS of 23.7 months compared with 20.6 months from lenvatinib or sorafenib.

Daratumumab would become the sole anti-CD38 agent available for all newly diagnosed multiple myeloma types if approved.

Data from the DESTINY-Breast06 trial support the positive opinion on trastuzumab deruxtecan as a treatment in HER2-low or HER2-ultralow breast cancer.

Pirtobrutinib demonstrated PFS benefit compared with standard of care in patients with relapsed or refractory CLL in the BRUIN CLL-321 trial.

Data from the phase 3 STARGLO study support the CHMP’s recommendation for approving glofitamab plus gemcitabine/oxaliplatin in relapsed/refractory DLBCL.

Despite prior relapses, 200 mg of linvoseltamab elicited complete responses or better in 49.6% of patients with relapsed/refractory multiple myeloma.

Isatuximab plus bortezomib, lenalidomide, and dexamethasone demonstrated enhanced MRD-negativity rates and a PFS benefit in patients with newly diagnosed multiple myeloma.

LITESPARK-004 and LITESPARK-005 trial results support the approval of belzutifan in patients with associated localized or advanced clear cell RCC.

Support for the recommendation is based on phase 3 ADRIATIC trial results showing a 27% reduction in the risk of death with durvalumab vs placebo.

Findings from the CheckMate 9DW trial support the CHMP’s recommendation for approving nivolumab/ipilimumab for those with unresectable HCC.

The TRANSCEND FL trial showed that liso-cel elicited an ORR of 97.1% and a complete response rate of 94.2% in patients with follicular lymphoma.

Patients who received the isatuximab combination in the IMROZ trial experienced prolonged MRD-negativity, which correlated with improved PFS.

Dostarlimab/chemotherapy elicited a 31% decrease in the risk of death compared with placebo/chemotherapy in locally advanced/recurrent endometrial cancer.

Additionally, the Chinese Society of Clinical Oncology and Chinese Anti-Cancer Association guidelines recommend the isatuximab regimen for this population.

The approved combination of enfortumab vedotin and pembrolizumab provides an alternative to chemotherapy for patients in China.

Findings from the phase 3 SACHI trial support the National Medical Products Administration’s priority review designation for savolitinib/osimertinib.

The decision is supported by results from the phase 2 TRUST-1 trial, which evaluated the safety and efficacy of taletrectinib in ROS1-positive NSCLC.

Feedback from the European Medicines Agency following results of the phase 3 TROPION-Lung01 informed the marketing authorization application withdrawal.

The European Commission has approved ribociclib plus an aromatase inhibitor for patients with early breast cancer.

The European Commission has approved tislelizumab plus chemotherapy as treatment for patients with esophageal and gastric or GEJ cancer.

Results from the TRIDENT-1 and CARE trials, which showcased durable activity and robust responses with repotrectinib, supported the recommendation.

The CHMP recommended for approval nivolumab/ipilimumab for patients with MSI-H and dMMR unresectable or metastatic colorectal cancer.

National Comprehensive Cancer Network updated 2 guideline resources to keep providers and other stakeholders up to date on cutting-edge genetic research.

Data from KEYNOTE-868 and KEYNOTE-A18 support the approval of pembrolizumab-based therapy in endometrial and cervical cancer, respectively.

Phase 3 EV-302 results supported the approval, showing a statically significant survival benefit compared with chemotherapy in urothelial carcinoma.

Data from the GLOW and SPOTLIGHT trials support the European Commission’s approval of zolbetuximab for patients with CLDN18.2-positive gastric cancer.

A belantamab mafodotin combination regimen has been accepted for review in Japan, based on data from the DREAMM-7 and DREAMM-8 clinical trials.

Data from the phase 2 PHAROS trial support the European Commission’s approval of encorafenib/binimetinib in NSCLC harboring a BRAF V600E mutation.

Second-line fruquintinib plus paclitaxel did not sustain sufficient efficacy for patients with advanced gastric or GEJ adenocarcinoma to support approval in China.

The decision follows phase 3 EV-302 trial findings showing improved survival with enfortumab vedotin plus pembrolizumab vs chemotherapy in urothelial cancer.