Keytruda and Keytruda Qlex
Q2 2026 sales $8.37B, up 5%; the largest drug franchise in the company and US patent protection expires in 2028.
The numbers
What it is
Pembrolizumab, an anti-PD-1 immunotherapy used across many cancers, given intravenously as Keytruda or subcutaneously as Keytruda Qlex. Growth in 2026 comes mainly from earlier-stage indications such as triple-negative breast, cervical, head and neck and bladder cancers.
Why it matters to the stock. Keytruda is about half of Merck's revenue, so its volume, pricing and the timing of its patent expiry drive the whole stock. The subcutaneous Qlex version is the company's main lever to protect that franchise.
News
Dutch court finds Keytruda SC infringes Halozyme patent, barring sales in eight European countries
A Dutch patent court found that Merck's subcutaneous Keytruda infringes Halozyme's EP 2,797,622 patent and rejected Merck's argument that the patent is invalid.
Japan approves Keytruda Qlex for subcutaneous use across all approved Keytruda indications
Japan approved Keytruda Qlex, the subcutaneous form of Keytruda, for every Keytruda indication already approved in Japan.
Merck and Moderna say personalized melanoma vaccine plus Keytruda met primary endpoint in Phase 3
Merck and Moderna announced topline Phase 3 INTerpath-001 results: intismeran autogene plus Keytruda beat Keytruda alone on recurrence-free survival in 1,137 patients with completely resected high-risk melanoma.
Merck Q2 2026 sales rise 5% to $16.6B; 2026 EPS guidance cut to $2.66-2.76 on acquisition charges
Merck reported second-quarter 2026 sales of $16.61 billion, up 5% (4% excluding FX), with Keytruda and Keytruda Qlex at $8.37 billion.
FDA approves Keytruda plus Padcev before and after surgery for cisplatin-eligible bladder cancer
The FDA approved Keytruda and Keytruda Qlex, each combined with Padcev, for adults with muscle-invasive bladder cancer who are eligible for cisplatin, given before cystectomy and continued after surgery.
FDA approves Keytruda and Keytruda Qlex with Trodelvy as first-line PD-L1-high triple-negative breast cancer treatment
The FDA approved Keytruda and Keytruda Qlex, each combined with Trodelvy (sacituzumab govitecan), as first-line treatment of adults with unresectable locally advanced or metastatic triple-negative breast cancer whose tumors express PD-L1 (CPS of 10 or more).
FDA approves Welireg with Keytruda or Keytruda Qlex for adjuvant clear cell kidney cancer
The FDA approved Welireg (belzutifan) in combination with Keytruda or Keytruda Qlex for adjuvant treatment of adults with clear cell renal cell carcinoma at intermediate-high or high risk of recurrence after nephrectomy.
Merck Q1 2026 sales rise 5% to $16.3B; non-GAAP loss of $1.28 per share after Cidara charge; guidance raised
Merck reported first-quarter 2026 sales of $16.3 billion, up 5% (3% excluding currency), with Keytruda and Keytruda Qlex at $8.0 billion, up 12%.
Welireg plus Keytruda cuts recurrence or death risk 28% in kidney cancer trial LITESPARK-022
Merck reported that adding Welireg to Keytruda reduced the risk of disease recurrence, metastasis or death by 28% versus Keytruda plus placebo in patients with earlier-stage clear cell kidney cancer at intermediate-high or high risk of recurrence.
FDA approves Keytruda and Keytruda Qlex for PD-L1-positive platinum-resistant ovarian cancer
The FDA approved Keytruda and Keytruda Qlex with paclitaxel, with or without bevacizumab, for adults with PD-L1-positive (CPS of 1 or more) platinum-resistant ovarian, fallopian tube or primary peritoneal cancer who have had one or two prior systemic regimens.
Merck reports Q4 2025 results and gives 2026 guidance of $65.5B-$67.0B sales and $5.00-$5.15 non-GAAP EPS
Merck reported fourth-quarter 2025 sales of $16.4 billion, up 5%, and full-year 2025 sales of $65.0 billion, up 1%.