Business Update & Financial Outlook
Driving value for patients and shareholders by progressing our pipeline
Key regulatory milestones
since the last earnings call:
• In the U.S., the FDA:
。 Granted approval of Lynparza' in combination with abiraterone and
prednisone in patients with deleterious or suspected deleterious BRCAM
metastatic castration-resistant prostate cancer
o Accepted sBLA for KEYTRUDA in combination with chemotherapy in
patients with locally advanced unresectable or metastatic biliary tract cancer
o Approved a new indication for PREVYMIS for prophylaxis of cytomegalovirus
(CMV) disease in adult kidney transplant recipients at high risk
○ Accepted the re-submission of NDA for gefapixant in patients with refractory
or unexplained chronic cough
• In the EU, the EMA:
o Accepted SMAA for KEYTRUDA in combination with trastuzumab and
chemotherapy in patients with locally advanced unresectable or metastatic
HER2-positive gastric or gastroesophageal junction adenocarcinoma
o Received positive CHMP opinion for gefapixant in patients with refractory or
unexplained chronic cough
• In Japan, the PMDA:
•
。 Granted approval of KEYTRUDA in patients with relapsed or refractory
primary mediastinal B-cell lymphoma
o Accepted sJNDA for KEYTRUDA in combination with chemotherapy in 1L
treatment of locally advanced unresectable or metastatic gastric or
gastroesophageal junction adenocarcinoma, as well as in patients with locally
advanced unresectable or metastatic biliary tract cancer
• Granted approval of VAXNEUVANCE in pediatrics
In China, the CDE:
。 Granted approval of Koselugo¹ for the treatment of symptomatic, inoperable
plexiform neurofibromas in pediatric patients with neurofibromatosis type I
ages 3 years and older
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Key data & clinical advancements
since the last earnings call:
Presented data across broad oncology portfolio at ASCO, including for
KEYTRUDA (KN-671, KN-483, KN-581, KN-716, KN-826), Lenvima², Lynparza¹,
WELIREG, mRNA-4157/V9403 (INT) and MK-2870/SKB2644 (TROP2 ADC)
Announced positive topline results for KN-811 evaluating KEYTRUDA in
combination with trastuzumab as 1L treatment in patients with HER2-positive
advanced gastric or gastroesophageal junction adenocarcinoma in PD-L1 positive
patients
Announced Phase 3 KN-A18 trial met primary endpoint of progression-free
survival in patients with newly diagnosed high-risk locally advanced cervical
cancer
Announced Phase 3 KN-756 trial met one of its dual primary endpoints of
pathological complete response rate in patients with high-risk, early-stage
ER+/HER2-breast cancer
Presented Phase 2a data at EASL for efinopegdutide (MK-6024), an
investigational GLP-1/glucagon receptor co-agonist, in patients with nonalcoholic
fatty liver disease (NAFLD), which has advanced to Phase 2b in nonalcoholic
steatohepatitis (NASH)
Completed BLA submission of sotatercept for pulmonary arterial hypertension
(PAH) to the FDA
Announced positive topline results from two Phase 3 trials evaluating V116 in
vaccine-naïve and previously vaccinated individuals
1. In collaboration with AstraZeneca 2. In collaboration with Eisai 3. In collaboration with Moderna 4. In collaboration with Kelun
MERCK
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