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Keytruda

All articles tagged with #keytruda

Moderna and Merck's personalized cancer vaccine fuels a new growth narrative
business1 month ago

Moderna and Merck's personalized cancer vaccine fuels a new growth narrative

Moderna and Merck reported positive Phase 3 data for intismeran autogene, a personalized cancer vaccine, in combination with Keytruda for melanoma, showing longer cancer-free survival versus Keytruda alone. The readout prompted stock upgrades and higher price targets for both companies, highlighting the potential of a market-of-one approach despite uncertainties about market size and applicability to other cancers. The vaccine’s roughly six-week manufacturing window enables concurrent treatment with Keytruda, raising the prospect of a new growth driver if similar results extend to other solid tumors; however, success in one cancer type does not guarantee broader approvals.

via Barron's|
#business#cancer-vaccine#intismeran-autogene
Personalized cancer vaccine from Moderna and Merck shows breakthrough in melanoma
health1 month ago

Personalized cancer vaccine from Moderna and Merck shows breakthrough in melanoma

Moderna and Merck reported a personalized mRNA cancer vaccine used with Keytruda that reduced melanoma recurrence and spread in a trial of more than 1,000 patients, with five-year data from earlier results showing about a 50% drop in recurrence and a 59% drop in spread versus Keytruda alone; if approved, thousands of melanoma patients could benefit in the first years, and trials in other cancers (lung, bladder, kidney, pancreatic, stomach) are ongoing with results expected in the coming years.

via CNN|
#cancer-vaccine#health#keytruda
Moderna and Merck's mRNA cancer vaccine shows promising melanoma results, lifting shares
business1 month ago

Moderna and Merck's mRNA cancer vaccine shows promising melanoma results, lifting shares

Moderna and Merck reported that their experimental mRNA cancer vaccine, intismeran, when combined with Merck’s Keytruda, produced a clinically meaningful improvement in high-risk melanoma across more than 1,100 patients, with safety consistent with prior studies; the trial could pave the way for a commercial launch next year and signals potential for an expanded mRNA cancer platform, triggering a sharp rally in Moderna’s stock and a solid gain for Merck.

via axios.com|
#business#intismeran#keytruda
Moderna-Merck mRNA vaccine shows promise in delaying melanoma recurrence
health1 month ago

Moderna-Merck mRNA vaccine shows promise in delaying melanoma recurrence

Moderna and Merck report interim Phase 3 results suggesting their personalized mRNA cancer vaccine Intismeran, used with Keytruda after melanoma surgery, may delay cancer recurrence in high-risk patients; data have not yet been peer‑reviewed and will be presented at a medical meeting and shared with regulators as the trial continues to assess overall survival.

via NBC News|
#health#immunotherapy#intismeran
Merck-Moderna melanoma vaccine combo shows phase 3 win for delaying recurrence
health1 month ago

Merck-Moderna melanoma vaccine combo shows phase 3 win for delaying recurrence

Merck and Moderna reported positive phase 3 results for a personalized mRNA cancer vaccine used with Keytruda in melanoma patients who had surgery, significantly extending disease-free survival and reducing the risk of distant metastasis versus Keytruda alone; safety was comparable to vaccines, and the teams will pursue regulatory submissions while continuing to assess overall survival.

via cnbc.com|
#health#keytruda#melanoma
Personalized mRNA cancer vaccine clears Phase 3 hurdle in melanoma
health1 month ago

Personalized mRNA cancer vaccine clears Phase 3 hurdle in melanoma

A patient-specific mRNA vaccine (intismeran autogene) combined with Keytruda met the Phase 3 primary endpoint in a 1,137-patient trial of resected melanoma, improving recurrence-free survival and potentially paving the way for the first FDA-approved mRNA-based cancer therapy; full data are to be presented later, with safety profile consistent with Keytruda.

via washingtonpost.com|
#cancer-immunotherapy#health#keytruda
Merck Q2 2026 Highlights: Oncology Momentum, FDA Wins, and Terns Deal Reshapes Guidance
business2 months ago

Merck Q2 2026 Highlights: Oncology Momentum, FDA Wins, and Terns Deal Reshapes Guidance

Merck posted 2Q26 sales of about $16.6B with KEYTRUDA/KEYTRUDA QLEX driving growth alongside WINREVAIR and Animal Health, while a $2.31 per-share charge tied to the Terns acquisition weighed on GAAP earnings and led to a narrowed full-year outlook of $66.3–$67.3B in sales and $2.66–$2.76 in non-GAAP EPS. The company highlighted FDA approvals for LIPFENDRA and several positive Phase 3 results across its oncology and HIV programs, plus continued progress across vaccines, immunology, and other pipeline milestones, including TroFuse-005 in endometrial cancer and ISL/LEN HIV regimens, as it advances its 2026 strategic plan.

via Merck.com|
#business#keytruda#lipfendra
Merck and Gilead Halt Phase 3 NSCLC Trial of Trodelvy with Keytruda After DMC Review
business4 months ago

Merck and Gilead Halt Phase 3 NSCLC Trial of Trodelvy with Keytruda After DMC Review

Merck and Gilead announced the discontinuation of the Phase 3 KEYNOTE-D46/EVOKE-03 trial evaluating Trodelvy in combination with Keytruda for previously untreated metastatic NSCLC with PD-L1 TPS ≥50% after the external Data Monitoring Committee reviewed the final PFS data and interim OS analysis. While progression-free survival improved numerically, it did not reach statistical significance, and the likelihood of a statistically significant overall survival result at the planned final analysis is low. Safety was consistent with the known profiles of both drugs. Regulators were informed, investigators and patients advised to discuss treatment with physicians, and there are no changes to ongoing Trodelvy or Merck studies. Data will be presented at a future medical meeting.

via Merck.com|
#business#gilead#keytruda
SMMT Climbs on Ivonescimab Survival Edge as Keytruda Rivalry Intensifies
business4 months ago

SMMT Climbs on Ivonescimab Survival Edge as Keytruda Rivalry Intensifies

Summit Therapeutics (SMMT) surged after ASCO data showed Ivonescimab plus chemotherapy extended overall survival in advanced squamous NSCLC to 27.9 months vs 23.7 with a PD-1 inhibitor, with about 65% alive at two years versus 49% in the control. The results, independent of PD-L1 status, fuel investor optimism about Ivonescimab as a potential successor to Keytruda and have Pfizer, Bristol Myers Squibb, and Merck pursuing rival PD-(L)1xVEGF therapies. SMMT also has an FDA review for Ivonescimab in EGFR-mutated lung cancer, while retail sentiment on Stocktwits turned extremely bullish despite some regulatory questions about China-sourced data. Big Pharma stocks mostly declined overnight.

via Yahoo Finance|
#asco#business#ivonescimab
Regeneron’s fianlimab setback puts melanoma program at a crossroads
business4 months ago

Regeneron’s fianlimab setback puts melanoma program at a crossroads

Regeneron’s phase 3 trial of fianlimab with Libtayo failed to beat Merck’s Keytruda as first-line therapy for unresectable melanoma, missing the primary endpoint of progression-free survival despite a numerical edge at the high dose; analysts say late separation of survival curves drove the non-significant result, signaling renewed pipeline pressure even as Regeneron pursues potential salvage paths (head-to-head vs Opdualag) and continues other programs (Factor XI, cemdisiran-pozelimab) as future catalysts.

via Fierce Biotech|
#business#fianlimab#keytruda
OX40-boosted Keytruda shows stronger responses in Inhibrx phase 2 HNSCC trial
healthcare5 months ago

OX40-boosted Keytruda shows stronger responses in Inhibrx phase 2 HNSCC trial

Inhibrx reports phase 2 HexAgon results showing INBRX-106, a hexavalent OX40 agonist, added to Merck’s Keytruda, doubling the objective response rate to 44% vs 21.4% for Keytruda alone in treatment‑naïve, high PD-L1 HNSCC (CPS ≥20), with three complete responses in the combo arm. Progression-free survival data will be shared in Q4, and a phase 3 study is planned for Q3, with expansion into NSCLC and other combinations on the roadmap. Reuters‑reported interest from Merck and others could fuel takeover talks if data remain favorable.

via Fierce Biotech|
#healthcare#hnscc#immunotherapy
LITESPARK-012 RCC Trial: Triplet Regimens Fail to Beat Standard Front-Line Therapy
healthcare5 months ago

LITESPARK-012 RCC Trial: Triplet Regimens Fail to Beat Standard Front-Line Therapy

Merck and Eisai reported interim results from Phase 3 LITESPARK-012 in first-line advanced clear cell RCC, showing that the triplet regimens (KEYTRUDA+LENVIMA+WELIREG and MK-1308A+LENVIMA) did not meet the dual primary endpoints of progression-free survival and overall survival versus KEYTRUDA+LENVIMA. Safety aligned with prior data, and full data analysis is ongoing with plans to share results with investigators and the scientific community. The findings do not affect other LITESPARK trials, and KEYTRUDA+LENVIMA remains an approved first-line RCC option; FDA has also accepted sNDA for LITESPARK-011 with a target action date of Oct 4, 2026.

via Merck|
#healthcare#keytruda#lenvima
Keytruda's fortress: Merck's patent-and-pricing empire under global scrutiny
business5 months ago

Keytruda's fortress: Merck's patent-and-pricing empire under global scrutiny

An ICIJ investigation shows Merck’s Keytruda has become one of the world’s best-selling drugs not just because of therapeutic value but due to an expansive patent portfolio (more than 1,200 filings in 53 countries), lobbying, and pricing tactics that raise costs for patients worldwide while governments and insurers struggle to fund access; the report details price disparities, secrecy, accelerated approvals, and strategic moves like drug-dosing and product hopping that help Merck extend monopoly into the 2030s, with patients in India, Guatemala, the U.S. and elsewhere paying vast out-of-pocket or facing restricted access.

via International Consortium of Investigative Journalists - ICIJ|
#access-to-medicine#business#drug-pricing