Merck & Co Stock Price, News & Analysis

Merck (NYSE: MRK) and Eisai announced positive results from the Phase 3 LEAP-012 trial evaluating KEYTRUDA® (pembrolizumab) plus LENVIMA® (lenvatinib) in combination with transarterial chemoembolization (TACE) for treating unresectable, non-metastatic hepatocellular carcinoma (HCC). The study showed:

1. 34% reduction in the risk of disease progression or death compared to TACE alone
2. Median progression-free survival (PFS) of 14.6 months vs 10.0 months for TACE alone
3. Trend toward improved overall survival, though data not yet mature
4. Safety profile consistent with previous studies

The results, presented at ESMO Congress 2024, highlight the potential of this combination therapy to extend PFS in patients with unresectable, non-metastatic HCC.

Merck's KEYTRUDA (pembrolizumab) plus chemoradiotherapy (CRT) showed significant benefits in treating high-risk locally advanced cervical cancer. The Phase 3 KEYNOTE-A18 trial demonstrated:

- 33% reduction in death risk compared to CRT alone
- 36-month overall survival rate of 82.6% vs 74.8% for CRT alone
- First positive overall survival results for an immunotherapy-based regimen in this patient group

The study, presented at the ESMO Congress 2024, could potentially change the treatment paradigm for these patients. KEYTRUDA's safety profile was consistent with previous studies, with no new safety signals identified.

Merck (NYSE: MRK) announced significant overall survival (OS) results from the Phase 3 KEYNOTE-811 trial evaluating KEYTRUDA® (pembrolizumab) in combination with trastuzumab and chemotherapy for first-line treatment of HER2-positive advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma. The KEYTRUDA regimen demonstrated:

- 20% reduction in risk of death (HR=0.80) compared to trastuzumab and chemotherapy alone
- Median OS of 20.0 months vs 16.8 months
- 21% reduction in risk of disease progression or death in patients with PD-L1 expressing tumors (CPS ≥1)
- Consistent safety profile with previous studies

These results support the existing accelerated approval in the U.S. and recent approval in the EU for this indication.

Merck (NYSE: MRK) announced that Joseph Romanelli, president of Human Health International, will participate in a fireside chat at the Bank of America 2024 Global Healthcare Conference. The event is scheduled for Wednesday, Sept. 18, 2024, at 6:40 a.m. EDT / 11:40 a.m. BST.

Investors, analysts, media members, and the general public are invited to listen to a live audio webcast of the presentation. Merck, known as MSD outside of the United States and Canada, has provided a weblink for interested parties to access the live stream.

This participation in a major healthcare conference highlights Merck's ongoing engagement with the investment community and its commitment to sharing insights about its international human health operations.

Merck (NYSE: MRK) has announced positive top-line results from its Phase 3 trial evaluating GARDASIL®9, its 9-valent Human Papillomavirus (HPV) vaccine, in Japanese males aged 16 to 26. The trial met its primary and secondary endpoints, demonstrating that a 3-dose regimen of GARDASIL 9 reduced the combined incidence of anogenital persistent infection caused by 9 types of HPV compared to placebo.

Dr. Eliav Barr, senior vice president at Merck Research Laboratories, emphasized the company's commitment to preventing HPV-related cancers through broad and equitable access globally. Merck plans to share these data with regulatory authorities in Japan and other countries to support licensure for use in males. Additionally, an ongoing confirmatory Phase 3 trial is evaluating the vaccine's efficacy in preventing HPV oral persistent infection to support effectiveness against HPV-related oropharyngeal and other head and neck cancers.

Daiichi Sankyo and Merck's ifinatamab deruxtecan (I-DXd) shows promising results in treating extensive-stage small cell lung cancer (ES-SCLC) in the IDeate-Lung01 phase 2 trial. Key findings include:

- 54.8% objective response rate at 12 mg/kg dose
- Median overall survival of 11.8 months at 12 mg/kg dose
- 50% intracranial response rate in patients with brain lesions
- 12 mg/kg selected as optimal dose for further studies

The safety profile is consistent with previous trials, with no new safety signals identified. These results support the potential of B7-H3 as a target in SCLC treatment.

Merck (NYSE: MRK) will present new data for 10 investigational or approved medicines at the ESMO Congress 2024 in Barcelona. Key highlights include:

1. Overall survival (OS) data for KEYTRUDA in early-stage triple-negative breast cancer and locally advanced cervical cancer.

2. Ten-year OS data from KEYNOTE-006 and final OS data from KEYNOTE-811 for KEYTRUDA in advanced melanoma and HER2-positive gastric cancer.

3. Progress in Merck's pipeline of antibody-drug conjugates (ADCs), including patritumab deruxtecan, sacituzumab tirumotecan, and ifinatamab deruxtecan.

4. Data on WELIREG for advanced renal cell carcinoma and LENVIMA for hepatocellular carcinoma.

The presentations showcase Merck's continued progress in advancing clinical research across a broad portfolio and diverse pipeline of investigational candidates.

Merck (NYSE: MRK) and its subsidiary EyeBio have initiated the Phase 2b/3 BRUNELLO trial for Restoret™ (MK-3000) in treating diabetic macular edema (DME). MK-3000 is an investigational, potentially first-in-class tetravalent, tri-specific antibody acting as an agonist of the Wnt signaling pathway. The trial's initiation follows promising results from the Phase 1/2 AMARONE study of MK-3000 in patients with DME and neovascular age-related macular degeneration (NVAMD). Dr. David Guyer, CEO of EyeBio, emphasized the potential of MK-3000 for retinal disease patients and highlighted the significance of the BRUNELLO trial in developing new treatment options for DME.

Merck's KEYTRUDA (pembrolizumab) in combination with Padcev (enfortumab vedotin-ejfv) has received European Commission approval for first-line treatment of unresectable or metastatic urothelial carcinoma in adults. This approval follows positive results from the Phase 3 KEYNOTE-A39 trial, which showed significant improvements in overall survival and progression-free survival compared to platinum-based chemotherapy.

Key findings include:

• 53% reduction in risk of death
• 55% reduction in risk of disease progression or death

This marks the first new first-line standard of care for this condition in decades, potentially extending patients' lives. KEYTRUDA is now approved for 28 indications in the EU, including three in bladder cancer.