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Merck has reported the P-III (LITESPARK-022) trial data assessing Keytruda (400mg, Q6W, IV) + Welireg (120mg, QD, PO) vs Keytruda + PBO for 1yr. in 1,841 pts with clear cell RCC following nephrectomy
At 28.4mos. mFU, the trial showed improved DFS (1EP), reducing the risk of disease recurrence or death by 28%, with mDFS…
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Merck has reorganized its Human Health division into two units: Oncology, and Specialty, Pharma & Infectious Diseases, to sharpen commercial execution & support a growing portfolio of launches across diverse therapeutic areas
Jannie Oosthuizen has been appointed EVP & President, Oncology & MSD International, while Brian Foard will serve as EVP & President, Specialty,…
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The US FDA has approved Keytruda/Keytruda Qlex + paclitaxel ± Avastin for the treatment of adults with PD-L1+ (CPS ≥1) Pt-resistant epithelial ovarian, fallopian tube or primary peritoneal carcinoma, who have received 1 or 2 prior systemic therapy
Approval was based on the P-III (KEYNOTE-B96/ENGOT-ov65) trial data assessing Keytruda (400mg, IV, Q6W) with CT…
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2025 pharma M&A was defined by fewer but more transformational deals, with companies prioritizing commercial-stage assets, late-stage pipelines, and platform technologies capable of reshaping long-term growth and strengthening core therapeutic franchises
The year’s momentum was led by three standout transactions, J&J’s $14.6B acquisition of Intra-Cellular Therapies, Novartis’ $12B deal for Avidity Biosciences, and Merck’s…
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Merck has initiated P-III (KANDLELIT-007) trial of calderasib (MK-1084) + Keytruda Qlex for the 1L treatment of pts with KRAS G12C-mutant, advanced or metastatic nonsquamous NSCLC
Trial will assess calderasib (PO, QD) + Keytruda Qlex (SC; Q6W) vs Keytruda Qlex + pemetrexed (IV) + CT in ~ 675 newly diagnosed pts with KRAS G12C-mutant nonsq. NSCLC, evaluating PFS as 1EP…
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The P-III (KEYNOTE-B15/EV-304) trial assessed 4 cycles of Keytruda (IV) + Padcev (IV), followed by surgery & then Keytruda (IV, 13 cycles) plus Padcev (IV, 5 cycles) vs neoadj. SoC + surgery in cisplatin-eligible MIBC pts (n=808)
Trial showed that perioperative combination of Keytruda + Padcev significantly improved EFS, OS & pCR rates vs…
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The P-III (MK-8591A-053) trial data assessed 100mg doravirine/0.25mg islatravir (DOR/ISL; QD, PO) vs 50mg bictegravir/200mg emtricitabine/25mg tenofovir alafenamide (BIC/FTC/TAF; QD, PO) ) in treatment-naïve adults with HIV-1 infection (n=537)
Trial met its primary efficacy hypothesis, with DOR/ISL showing non-inferiority to BIC/FTC/TAF in achieving HIV-1 RNA <50 copies/mL at Wk. 48, & also achieved its…
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The EC has approved Keytruda SC (pembrolizumab & berahyaluronidase alfa-pmph) for SC dosing in adults across all 33 Keytruda indications in all 30 EEA states, with availability subject to multiple factors, incl. national reimbursement processes
Approval was based on P-III (3475A-D77) trial assessing Keytruda SC (790mg/9600 units, Q6W; n=251) vs IV Keytruda (400mg, Q6W;…
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Merck Enters into Research and Development Funding Agreement with Blackstone Life Sciences to support development of sac-TMT, currently in 15 global P-III trials across multiple cancers, including breast, endometrial, and lung
As per the deal, Blackstone will provide Merck $700M to help fund sac-TMT development through 2026. In return, Blackstone is eligible for low-to-mid…
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The EC has approved neoadj. Keytruda followed by adj. Keytruda + SoC radiotherapy (RT) ± cisplatin & then as a single agent to treat operable LA-HNSCC tumors expressing PD-L1 (CPS ≥1) across all 30 EEA states
Approval was based on P-III (KEYNOTE-689) trial assessing neoadj. Keytruda (200mg, IV, Q3W × 2 cycles), followed by adj. Keytruda (15…

