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Merck & Eisai has reported the P-III (LITESPARK-011) trial data assessing Welireg (belzutifan; 120mg, PO, QD) + Lenvima (lenvatinib; 20mg, PO, QD) vs cabozantinib in 747 pts with advanced RCC whose disease progressed on or after anti-PD-1/ PD-L1 therapy
At mFU of 29mos., trial met its 1EP of improved PFS by 30% (mPFS: 14.8 vs…
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Roche has reported P-III (FENhance 1) trial results in RMS pts, randomized to either fenebrutinib (PO, BID) with PBO-matched to teriflunomide or teriflunomide (PO, QD) with PBO matched to fenebrutinib
Trial met its 1EP, reducing ARR by 51% over ≥96wks., consistent with the P-III (FENhance 2) study showing 59% reduction, while 2EPs showed significant…
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The P-III (KEYNOTE-B15/EV-304) trial assessed Keytruda + Padcev (IV), followed by surgery & then Keytruda + Padcev vs neoadj. SoC + surgery in cisplatin-eligible MIBC pts
Trial showed 47% reduction in the risk of tumor recurrence, progression, or death, with an estimated 79.4% pts event-free at 2yrs. vs 66.2% with SoC, plus the combination…
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Galderma has reported OLYMPIA LTE study data assessing Nemluvio in 508 pts with prurigo nodularis up to 4yrs., from the P-II trial & the P-III (OLYMPIA 1 & 2) trials
At Wk. 148, >70% of pts had clear or almost clear lesions per IGA score, >85% achieved ≥75% of healed lesions by prurigo activity…
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Bayer has reported the P-III (PEACE-3) trial assessing Xofigo (radium-223 dichloride; 55kBq/kg, IV, QM for 6 cycles) + enzalutamide (160mg, PO, QD) vs enzalutamide in asymptomatic or mildly symptomatic pts (Brief Pain Inventory score <4) with mCRPC & ≥2 bone metastases
Trial showed improved OS (2EP), with a 24% reduction in death risk &…
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ViiV Healthcare has reported 12mos. interim data from P-IIb (EMBRACE) trial assessing lotivibart (IV or SC, Q4M) + cabotegravir (CAB LA; IM, QM) vs SoC for the treatment of HIV
lotivibart + cabotegravir maintained viral suppression in 94% of lotivibart IV & 82% of SC recipients vs 88%, with confirmed virologic failure in 4%…
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IDEAYA Biosciences has enrolled the first patient in its P-I dose escalation/expansion trial of IDE034, a B7H3/PTK7 bispecific TOP1 ADC, for solid tumors
The company is planning to assess the safety, tolerability, & PK of IDE034 as monotx. in a P-I trial & explore combinations with DDR-targeting agents, incl. its proprietary PARG inhibitor, IDE161…
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The US FDA has granted full approval to Braftovi + cetuximab & fluorouracil-based CT for the treatment of adults with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation
Approval was backed by the P-III (BREAKWATER) study assessing Braftovi (300mg, PO, QD) in pts, randomized to Braftovi + cetuximab (n=158), Braftovi + cetuximab + mFOLFOX6 (n=236),…
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J&J has reported the long-term data from the QUASAR LTE trial in pts with mod. to sev. active ulcerative colitis, showing lasting disease control for patients
The P-IIb/III (QUASAR) trial assessed Tremfya (IV induction: 200mg Q4W; SC maintenance: 100mg, Q8W or 200mg, Q4W) vs PBO in UC pts
At Wk. 140, ~89% completed treatment,…
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Partner Therapeutics has reported post-hoc analysis from the eNRGy study assessing zenocutuzumab (marketed as Bizengri in the US) in pts with advanced NRG1+ NSCLC
In 27 pts with NRG1+ NSCLC treated with zenocutuzumab (≥3 doses) beyond radiographic progression, 81% had oligoprogression & 19% diffuse progression, extending median exposure to ~10 vs ~7mos. pre-progression.
Additionally,…

