WHAT THE STUDY ACTUALLY SAYSAdding pembrolizumab plus maintenance olaparib to first-line chemotherapy improved progression-free survival — but pembrolizumab added without olaparib did nothing at all.
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WHAT THE STUDY ACTUALLY SAYSIn an early-phase trial of 136 previously treated patients, daraxonrasib produced responses in 31–37% depending on dose — but 54% had a serious side effect, and this is a phase 1–2 study.
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WHAT THE STUDY ACTUALLY SAYSIn the single-arm EPCORE NHL-2 cohort, adding epcoritamab to rituximab and lenalidomide produced responses in 95% of 41 untreated follicular lymphoma patients, with no control group to prove added benefit.
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THE DRUG DOCKETIn HERIZON-GEA-01, zanidatamab plus chemotherapy raised median progression-free survival to 12.4 months from 8.1 with trastuzumab. A clear survival gain came only when tislelizumab was added.
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WHAT THE STUDY ACTUALLY SAYSThe radioligand cut the risk of radiographic progression or death by 28% when added to standard therapy in a phase 3 trial — a real but incremental gain, bought with more side-effects.
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WHAT THE STUDY ACTUALLY SAYSIn KEYNOTE-B15/EV-304, perioperative enfortumab vedotin plus pembrolizumab lifted two-year event-free survival to 79.4% from 66.2% against standard cisplatin-based chemotherapy in patients fit for it.
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THE DRUG DOCKETThe targeted combination more than tripled progression-free survival versus placebo in iodine-refractory disease — but overall survival is not yet significant and the trial was mostly Asian.
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WHAT THE STUDY ACTUALLY SAYSIn the phase 3 BRUIN CLL-322 trial, adding pirtobrutinib to a fixed course of venetoclax and rituximab raised 24-month progression-free survival to 87% from 72% in previously treated disease.
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WHAT THE STUDY ACTUALLY SAYSIn the phase 3 LIBRETTO-432 trial, adjuvant selpercatinib raised two-year event-free survival to 92% from 61% in resected stage II-IIIA RET fusion-positive lung cancer. The trial was small and survival is unproven.
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THE DRUG DOCKETBeqalzi (sonrotoclax) is approved for relapsed mantle-cell lymphoma after a BTK inhibitor. Just over half of 103 patients responded in a single-arm trial with no survival data.
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THE DRUG DOCKETBizengri now covers NRG1-fusion cholangiocarcinoma, a mutation found in a fraction of a fraction of cases. The evidence is 19 patients, of whom about a third responded.
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WHAT THE STUDY ACTUALLY SAYSIn a Chinese phase 2–3 trial, neoadjuvant chemotherapy, lenvatinib and a PD-1 antibody before liver surgery lifted median event-free survival to 18.0 months from 8.7. The survival signal was not yet conclusive.
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WHAT THE STUDY ACTUALLY SAYSIn KEYNOTE-905/EV-303, adding enfortumab vedotin and pembrolizumab to surgery lifted two-year event-free survival to 74.7% from 39.4%. Serious side effects were common.
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WHAT THE STUDY ACTUALLY SAYSIn the phase 3 ASCENT-04 trial, sacituzumab govitecan with pembrolizumab lifted median progression-free survival to 11.2 months from 7.8 in PD-L1-positive disease. Survival data are immature.
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THE DRUG DOCKETHyrnuo (sevabertinib) is cleared for previously treated HER2-mutant NSCLC on response rate alone. The confirmatory trial that must justify it does not report until 2029.
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