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4 changes since 17 Jul 2026 - 7 Oct 2026 District Court of The Hague granted Halozyme an injunction under patent EP 2,797,622 ordering Merck's subsidiary MSD BV to stop making, supplying and importing Keytruda SC in Belgium, Denmark, France, Ireland, Italy, Sweden, Switzerland and the Netherlands; IV Keytruda is not covered. (Halozyme's own account of the ruling (party to the case); Merck's response not on our record) Halozyme press release, 7 Oct 2026 · 13 Sep 2026 HARMONi-2: ivonescimab monotherapy beats Keytruda monotherapy on overall survival (30.8 vs 22.6 months, HR 0.73, P=0.009) (reported by IASLC, interim analysis, peer review pending; presented 13 Sep) IASLC press release, 12 Sep 2026 · 4 Sep 2026 12-year data exclusivity lapsed 4 Sep 2026 - not the biosimilar entry date Merck FY2025 Form 10-K, Item 1, Patents, Trademarks and Licenses · 31 Jul 2026 US prescribing information revised FDA prescribing information (DailyMed), effective 2026-07-31
Latest quarter · Q2 2026
$8.37B▲5.2% YoY
Reported · vs Q2 2025
next: Q3 2026 · 29 Oct 2026 (announced)
Year to date · H1 2026
$16.4B▲8.2% YoY
Reported quarters, sum of reported quarters · vs H1 2025
Full year · FY2025
$31.7B▲7% YoY
Reported · Merck & Co. FY2025 results
Modelled peak
$38.9B2028
Model estimate · not risk-adjusted
US biologic LOE
2028
US exclusivity window · Merck FY2025 10-K
Reported, public fact, citedModel, Ormeval estimateHover any figure for its source.Tap any figure for its source.
Refresh cadenceFinancials · FY2025 reportedMarket & label · Q2 2026Catalysts · refreshed daily
Keytruda is still compounding on earlier-stage launches, but Merck's own filing says US biosimilar competition could begin in December 2028, and subcutaneous Qlex was $463M of an $8.37B franchise quarter in Q2 2026.
The 15-second verdict
Keytruda is still compounding on earlier-stage launches, but Merck's own filing says US biosimilar competition could begin in December 2028, and subcutaneous Qlex was $463M of an $8.37B franchise quarter in Q2 2026.
Can Qlex convert fast enough to hold volume through the 2028 cliff, when Merck says early use is still concentrated in monotherapy and oral-combination patients?
Bottom line
Not on the current run-rate, and the constraint is legal as much as commercial. Qlex carries its own issued US patent to 2043, so every converted patient is protected long past the IV cliff, which is why the $38.9B CONCLUDED peak (2028) survives 2028 at all; but the switch is one year old and still small against the base it has to replace, Halozyme's MDASE suit has already produced a preliminary injunction blocking German sales with the appeal due in Q2-Q3 2026, and Merck expects Keytruda to be picked for Medicare price setting in 2027 with the price effective January 2029.
◆ Ormeval scoping estimateThe $38.9B peak above is computed by the model, not company guidance.
The full bull / base / bear framing sits in the launch wave vs. threat bridge →
Keytruda and Keytruda Qlex sold $31,680M in CY2025, up 7% (Merck FY2025 Form 10-K), across "over 40 approved US indications" (reported by Merck, FY2025 Form 10-K, counting US label indications one by one; Ormeval's record counts 32 approved, a curated count of indication rows that groups label indications sharing one setting) (19 tumour types plus 2 tumour-agnostic) spanning NSCLC, melanoma, MSI-H tumours, urothelial, TNBC, gastric, cervical, RCC and beyond. The franchise is in its peak-to-LOE transition: Merck's 10-K says US biosimilar competition could begin December 2028, the defining event of the next 3 years. Subcutaneous Keytruda Qlex (SC + berahyaluronidase alfa, approved Sep 2025) is the principal lifecycle lever. The strategic question is how much volume Qlex retains vs IV biosimilars post-2028 across those settings.
Molecule
ClassPD-1 inhibitor
TargetPD-1
ModalityHumanised IgG4κ mAb
Intravenous200 mg every 3 weeks
Intravenous400 mg every 6 weeks
Subcutaneous395 mg/4,800 units every 3 weeks · adults and pediatric patients 12 years and older who weigh greater than 40 kg · §2.2
Safety & tolerability at a glanceFull profile →
Reported, FDA labelClass estimate1Reported rows are transcribed from the US prescribing information; dashed rows are class-level estimates. Open a row for the curated sentence behind it.
Development to approval
Development to approval
The approval came out of Phase 1, not Phase 3. KEYNOTE-001 (NCT01295827) opened on 4 March 2011 as a Phase 1 dose-escalation study that grew into a very large multi-cohort expansion basket, and it was the melanoma cohort of that Phase 1 study that supported the first-ever FDA approval of an anti-PD-1 therapy on 4 September 2014 under accelerated approval (BLA 125514). Both confirmatory trials STARTED before that approval - the registrational Phase 2, KEYNOTE-002 (NCT01704287), opened 20 November 2012, and the confirmatory Phase 3, KEYNOTE-006 (NCT01866319), opened 28 August 2013 - but their PRIMARY COMPLETION came after: KEYNOTE-002 reached it 16 November 2015, and KEYNOTE-006 reached it 3 March 2015, the date recorded as the 'Ph 3' milestone above. Sources: ClinicalTrials.gov NCT01295827, NCT01704287, NCT01866319.
9 sections · 7 curated · 1 derived · 1 engine-derived by design (7 of 8 curatable)
All 40 indication rows were checked against a named source, 16 Aug–16 Sep 2026.
A dash means that section is not yet curated for this asset and falls back to a derived estimate or an illustrative default, it is never presented as a sourced figure. ≈ marks a section the engine derived from the indication models rather than one curated for this asset; it is real output, but it is not counted as curated. A few sections carry the same ≈ permanently: the revenue mix is computed from the indication models and has no curated form to replace it, so it is shown but left out of the count rather than standing as a gap that never closes.
What it shows. The asset's revenue trajectory: reported actuals where available, then the modelled outlook, summed across all of its indications.
What to look for. The growth slope into peak and the drop after loss of exclusivity, that cliff is the defining risk for a marketed asset.
Common misread. The forward portion is a modelled scenario, not company guidance; and it is the asset total, the per-indication pages show what each one contributes.
Since 2026-09-29: peak $38.9B (2028) vs $38.9B (2028), unchanged; 2031 $18.4B vs $18.4B, unchanged
Solid line = reported revenue; dashed line and band = Ormeval's modelled outlook from the current year.
2 of the 4 headline figures are cited to a document; the other 2 are flagged model estimates.
How the $38.9B · 2028 peak is derivedCONCLUDED · model estimate
Model-derived, not company guidance: the $38.9B 2028 peak extends the reported trajectory (FY2025 $31.7B, +7% YoY) forward. An Ormeval model output, not company guidance or analyst consensus.
How accurate have our forecasts been? See the track record →
LOE Horizon: Merck's FY2025 10-K says US biosimilar competition could begin in December 2028 when the primary compound patent expires, with sales materially impacted across 2028-2029; two further composition-of-matter patents run to May and November 2029 and Merck expects them to be litigated.
Key threat, US biosimilar competition could begin December 2028, against a subcutaneous conversion still in its first year
resolves Dec 2028 (entry date); conversion measurable every quarter until thenThis is the only question on the asset. The BPCIA 12-year clock (4 September 2026) is already moot; the gate is the composition-of-matter estate, and Merck's FY2025 10-K puts it in its own hedged words: biosimilar competition "could begin in December 2028 when the primary compound patent expires". The hedge is load-bearing.
Two further patents in the same family run to May and November 2029, and the filing says Merck expects both to be litigated, which is why the same paragraph frames the exposure as a window rather than a date: sales "will be materially negatively impacted by biosimilar competition between 2028 and 2029". At least nine developers have pembrolizumab biosimilars in Phase 1-3 with trial completions clustering 2026-2029, though none has a confirmed 351(k) filing or a settled launch date - a genuine negative finding, not an omission. The whole defence is converting IV volume to the co-formulated subcutaneous product, Keytruda Qlex (FDA 19 September 2025, EU 19 November 2025), which Merck's own patent table carries to 2043 in the US, so every converted patient sits outside the IV cliff. The conversion is real and still early: Qlex was $40M of the $31.7B FY2025 franchise, then $128M against an $8.0B quarter in Q1 2026 and $463M against an $8.37B quarter in Q2 2026, after the permanent J-code took effect on 1 April 2026. Merck names the constraint on it without sizing it: early use "has been predominantly in patients who are either on monotherapy or in combination with an oral agent". That is the mechanism of any ceiling rather than an assertion about its height, and it is the right way round - a patient already receiving IV chemotherapy is in the chair regardless, so the subcutaneous route saves that visit nothing. Two further constraints run alongside it. Halozyme's MDASE litigation has already produced a preliminary injunction blocking German Qlex sales, with the appeal due Q2-Q3 2026. And Merck expects Keytruda to be selected in 2027 for IRA price setting, with the set price effective 1 January 2029 and US sales expected to "decline materially after that time" - immediately behind the biosimilar window, not after it.
◆ Ormeval scoping estimateEvery figure below is computed by the model from public sources. None is company guidance.
What's at risk
59.6% of sales
US share of the FY2025 franchise (record regional split 59.6%); it is the US IV label that opens
Timing
Dec 2028 earliest
the earliest date Merck's own filing gives, and it says 'could begin'; IRA price setting from 1 Jan 2029
Resolving readout
Qlex share of franchise revenue
$463M of the $8.37B Q2 2026 franchise quarter (5.5%), from $128M in Q1 2026 and $40M across all of FY2025
Model impact
−22% a year
the erosion rate the record already applies from 2028; the bull case is a faster Qlex switch, the bear case is the switch stalling where Merck says it has not yet reached
Want to edit assumptions and model scenarios? Set up your cockpit →
Every material move on this page, newest first, the public fact, and what our model made of it.
What recently moved · last 90 days
Keytruda's 12-year BPCIA reference-product exclusivity expires (first licensure 4 Sep 2014)
Share of modelled indication revenue · 2026 · 23 of 32 approved indications modelled · not the reported total (why)
The single biggest earner is 1L metastatic NSCLC (± chemo) at 43%.
Shares are of modelled net revenue in 2026 across the indications that carry a model; they are not shares of the reported FY figure, and the modelled values are not summed into a total here. Pre-revenue rows show the modelled peak. Every figure is an Ormeval model projection, not company guidance.
Regional revenue split
Disclosed shares · derived figures
Reference: Q2 2026 reported revenue of $8.37B, the latest reported earnings.
US
59.6%$4.98B
RoW
40.4%$3.39B
Percentages are Ormeval's regrouping (FY2025) of the regions the company itself reports; which regions those are, and how each was mapped, is in the basis note below; applying them to the Q2 2026 total is ours. Regions the company does not break out separately are not listed here, an absent region means “not separately disclosed”, never zero sales. Follow this asset to model your own.
Follow to edit →Loss of exclusivity is the forecast's biggest assumption. When it falls in each market, what gates it, who is coming, and what the forecast assumes.
1 · When, by market
today (2026) to the gating expiry
3 · Who is coming
as of 2026-09-22 · ClinicalTrials.gov API v2
Counts trialled programmes only, as of 2026-09-22. Announced-but-untrialled programmes: a sponsor with no interventional study on ClinicalTrials.gov is not counted.
| Sponsor | Programme | Registry records |
|---|---|---|
| Bio-Thera Solutions | BAT3306 |
|
| Formycon AG | FYB206 |
|
| Samsung Bioepis Co., Ltd. | SB27 |
|
| Sandoz | GME751 |
|
| Shanghai Henlius Biotech | HLX17 |
|
| Amgen | ABP 234 |
|
| Biocon Biologics UK PLC | Not named |
|
| Celltrion | CT-P51 |
|
| Laboratorio Elea Phoenix S.A. | MB12 |
|
| mAbxience Research S.L. | MB12 |
|
| Qilu Pharmaceutical Co., Ltd. | QL2107 |
|
Primary completion dates and 351(k) / MAA filings are not in the registry snapshot of 2026-09-22, so neither is shown for any programme.
No confirmed BPCIA patent-dance litigation, settlement, or disclosed biosimilar entry date was found for pembrolizumab specifically - this is a genuine negative finding, not an omission. 11 sponsors with pembrolizumab biosimilar trials on ClinicalTrials.gov as of 2026-09-22. Programmes announced but not yet registered as trials are not counted. None has a confirmed 351(k) filing or settled US launch date. Sponsors, with their registered trials: Bio-Thera Solutions (NCT06111196, PHASE1, completed; NCT06280196, PHASE3, terminated; NCT07180862, PHASE1, active not recruiting), Formycon AG (NCT06551064, PHASE1, active not recruiting; NCT06643117, PHASE3, terminated), Samsung Bioepis Co., Ltd. (NCT06268613, PHASE1, active not recruiting; NCT06348199, PHASE3, active not recruiting), Sandoz (NCT06153238, PHASE1, completed; NCT06159790, PHASE3, completed), Shanghai Henlius Biotech (NCT06847334, PHASE3, not yet recruiting; NCT07160335, PHASE1, active not recruiting), Amgen (NCT06311721, PHASE3, active not recruiting), Biocon Biologics UK PLC (NCT07581509, PHASE1, not yet recruiting), Celltrion (NCT06939595, PHASE3, active not recruiting), Laboratorio Elea Phoenix S.A. (NCT05668650, PHASE3, unknown), mAbxience Research S.L. (NCT06687369, PHASE3, active not recruiting), Qilu Pharmaceutical Co., Ltd. (NCT07162883, PHASE3, not yet recruiting).
4 · What the forecast assumesModel
The erosion assumption is drawn on the revenue outlook.
2 · What gates it
statuses as of Oct 15, 2026
Modality Biologic - humanized IgG4 monoclonal antibody (anti-PD-1), licensed via BLA (not in the FDA Orange Book; governed by the BPCIA/Purple Book framework, not Hatch-Waxman NCE rules) · First licensure 4 Sep 2014 (US, FDA accelerated approval, BLA 125514, melanoma - the first-ever FDA-approved anti-PD-1 therapy)
| Layer | Date | Status | Source |
|---|---|---|---|
Reference-product exclusivity (BPCIA, 12-year)Computed as exactly 12 years after the verified first-licensure date (4 Sep 2014) under BPCIA 351(k)(7); this only sets when FDA could accept a biosimilar application, not a market-entry guarantee | 4 Sep 2026 | lapsed | Merck press release confirming BLA 125514 accelerated approval, 4 Sep 2014 |
Core composition-of-matter patent (US 8,900,587, Antibodies to human PD-1)Merck's FY2025 Form 10-K: Keytruda biosimilar competition "could begin in December 2028 when the primary compound patent expires". The issuer's own filed date; the month a third-party patent record lists (Aug 2028) is not used | Dec 2028Dec 2028 (US; Merck FY2025 Form 10-K) | confirmed | Merck FY2025 Form 10-K (SEC EDGAR) |
Secondary method-of-use and combination-therapy patent estateMerck's FY2025 Form 10-K dates Keytruda biosimilar competition to the primary compound patent: it "could begin in December 2028 when the primary compound patent expires". No expiry date for an individual secondary (dosing, combination or manufacturing) patent was read from a primary record, so none is stated; this layer is an unverified absence, not an estimate of a date | Expiry not disclosed; Undisclosed - no primary record states a date for this layer | expected | Merck FY2025 Form 10-K (SEC EDGAR) |
Earliest likely entry: December 2028, at the earliest (US, compound-patent gated; Merck's own word is "could"), with two further composition-of-matter patents running to May and November 2029
Settled against the filing itself on 2026-09-02, and the answer is a window rather than a date. Merck's FY2025 Form 10-K states that Keytruda sales "will be materially negatively impacted by biosimilar competition between 2028 and 2029", and that "while two patents in the Keytruda composition of matter patent family expire in May and November of 2029, respectively, the Company expects these patents to be the subject of litigation and, thus, biosimilar competition could begin in December 2028 when the primary compound patent expires". The same filing's patent table lists Keytruda at US 2028, EU 2031, Japan 2032-2033, China 2028, with footnote (10) explaining that the two 2029 patents exist only because of patent term adjustment for patent-office delay. So December 2028 is the earliest date the company itself will name, it is conditioned on litigation Merck expects, and the BPCIA 12-year exclusivity (September 2026) was never the gate. No 351(k) filing has been confirmed and the clinical-stage biosimilar field has completions clustering 2026-2029, consistent with the same window. The sponsor list is derived, not typed: see the competitors note, which reads it off the ClinicalTrials.gov census. The previous hand-typed list here named BioNTech, which has no registered pembrolizumab biosimilar trial (BNT327 is a novel bispecific, not a copy), and omitted three sponsors that do.
How to read this: Confirmed against primary sources: licensure date, BLA number, the 12-year BPCIA arithmetic, and (new on 2026-09-02) the entry window, the two 2029 family patents and the Keytruda Qlex US 2043 date, all read directly from Merck's FY2025 Form 10-K on SEC EDGAR. RESOLVED: the "August vs December 2028" conflict this note used to record was an artefact of never having opened the filing.
EDGAR had refused earlier scripted attempts, so the record was reasoning from press summaries of a document it had not read. It is December 2028, hedged as "could begin"; the August date does not appear in the filing. The separate source citing a 2036 US date remains unreconciled, most likely a different patent in the family; it is not relied on here. STILL TRUE and worth keeping: no settled biosimilar entry date exists publicly, so do not present one as fact. The near-term commercial driver through 2026-2028 remains the patent estate and the Qlex conversion, not biosimilar competition, since no near-term launch is corroborated.
Erosion removes $20.4B by 2031; launches replace $2.92B
From reported FY2025 revenue ($31.7B, company-reported) to the outlook chart's 2031 value ($18.4B, model estimate). Erosion is the loss-of-exclusivity tail the chart applies from 2028 at 22% a year, one onset for all markets. In-line is the rest of the chart's change on the approved base. Launches are 5 of 5 pre-approval settings valued in 2031 from their indication models. 23 of 32 approved indications modelled. Bucket rules v1 (2026-09-26).
One onset (2028) for all markets is a simplification: a by-market onset would defer at most ~$8.26B of the $20.4B erosion past 2031 (the 40% outside the US; less in practice, since some non-US markets lose exclusivity in 2028 too).
Every bar but the first is an Ormeval model estimate, not company guidance. Bucket rules v1 (2026-09-26).
What would change our mindThis bridge is DERIVED, not curated: it is arithmetic over the indication models, so it inherits every assumption in them and knows nothing this platform has not already modelled. It would be wrong if a pre-approval indication fails outright - the engine carries no probability of success here - or if the approved base erodes faster or slower than the modelled erosion from 2028 assumes. Treat a curated bridge, where one exists, as strictly better evidence than this one.
KEYNOTE-676 · Phase III readouts · High-risk non-muscle-invasive bladder cancer, BCG-naive and post-BCG (with BCG) · 2027
ClinicalTrials.gov registry · Source ↗
What it decides: whether KEYNOTE-676 is positive in High-risk non-muscle-invasive bladder cancer, BCG-naive and post-BCG (with BCG), the pivotal evidence for a label there.
| Indication | H2 2026 (0)est. timing | 2027 (5)est. timing | 2028 (0)est. timing |
|---|---|---|---|
| Biliary tract cancer, + gemcitabine / cisplatin |
| ||
| High-risk non-muscle-invasive bladder cancer, BCG-naive and post-BCG (with BCG) |
| ||
| Limited-stage SCLC, concurrent chemoradiation (with/without olaparib) |
| ||
| Muscle-invasive bladder cancer, bladder-preservation chemoradiation · Primary BI-EFS |
| ||
| Unresectable stage III NSCLC, concurrent chemoradiation (with/without olaparib) |
|
Regulatory decision Submission Ph3 readout Ph2 readout Other achieved, links to the primary source
estimated timing spread across the stated period
✓ = reported public fact, cited. Upcoming timing is estimated from company guidance & trial registries, a projection, not a commitment.
What it shows. Upcoming data readouts, regulatory decisions and LOE events across this asset and its competitive field, on one rolling calendar. Recent reported moves, and what each did to the model, are in the change history above.
What to look for. The near-term catalysts that could move the thesis, and whether each is the company's own event or a competitor's (the owner is tagged).
Common misread. Not every catalyst here is the company's own, some are rival readouts that pressure the asset rather than help it.
| Asset | Company | Trajectory | Latest quarter | FY latest | US LOE | Approved | Pipeline (Ph I · II · III · filed) |
|---|---|---|---|---|---|---|---|
| Opdivo | Bristol Myers Squibb | $2.48BQ2 26 | $10.0BFY 25 | 2028 | 23 | 0 · 0 · 3 · 0 | |
| Imfinzi | AstraZeneca | $1.85BQ2 26 | $6.06BFY 25 | ~2031 | 11 | 0 · 8 · 11 · 0 | |
| Tecentriq | Roche | $1.07BQ2 26 | $4.28BFY 25 | 2030 | 9 | 0 · 0 · 2 · 1 | |
| Libtayo | Regeneron | $438MQ1 26 | $1.45BFY 25 | 2035 | 5 | 0 · 8 · 3 · 0 |
1 Product revenue as recorded by the company in the Company column, for scale within Keytruda's tracked competitive set, not the total market. 2 In USD at a fixed reference rate; % reported in the reporting currency. 3 As of Q2 2026 reported figures.
Contested revenue · who competes in the top settings
A rival's total revenue isn't a head-to-head number, competition happens setting by setting. For Keytruda's biggest revenue settings: the modelled revenue at stake and the rivals that actually compete for it.
Latest threat HARMONi-2 (Ivonescimab) · 30.8 vs 22.6 months, HR 0.73, P=0.009 (reported by IASLC, interim analysis, peer review pending; presented 13 Sep) · 13 Sep 2026 · source
Per-setting share, comparator and access-lag detail sit on each indication page. Tracked rivals (↗) link to their own asset page.
Zoom out: see how Merck & Co.'s launch wave offsets the LOE cliff →
What it shows. The rival agents to this asset and their scale, so you can see the competitive field it sits in.
What to look for. Which rivals overlap in the asset's biggest indications, and which are ex-US or a different line of therapy.
Common misread. A rival's total revenue is not a head-to-head number, competition happens indication by indication; use the indication pages for setting-level share.
Swipe to explore →Scroll sideways for every column →
| KEYNOTE-001 / -006 | Advanced / metastatic melanoma | Approved | HR 0.73 · OS benefit (5-yr) | · | 2014-09-04 | 2015-07-22 | not itemised | not itemised | $2.97B (2021) |
| KEYNOTE-189 / -407 / -024 | 1L metastatic NSCLC (± chemo) | Approved | HR 0.60 · OS benefit (KN-189) | Q4 2016 | 2016-10-24 | Q1 2017 | Q1 2019 | Q1 2017 | $13.8B (2024) |
| KEYNOTE-158 | MSI-H / dMMR solid tumors (tumor-agnostic) | Approved | 30.8% · ORR (non-CRC MSI-H) | · | 2017-05-23 | 2022-04-29 | not itemised | not itemised | $822M (2024) |
| KEYNOTE-087 / -204 | Relapsed / refractory classical Hodgkin lymphoma | Approved | ~69% · ORR (KEYNOTE-087) | · | 2017-03-14 | 2021-03-17 | not itemised | not itemised | $149M (2022) |
| KEYNOTE-054 / -716 | Adjuvant melanoma (stage IIB–III) | Approved | HR 0.57 · RFS (stage III, KN-054) | · | 2019-02-15 | 2018-12-17 | not itemised | not itemised | $1.47B (2024) |
| KEYNOTE-826 / -158 | Cervical, 1L + chemo ± bevacizumab / 2L monotherapy | Approved | HR 0.63 · OS benefit (KN-826, CPS≥1) | · | 2018-06-12 | 2022-04-29 | not itemised | not itemised | $1.02B (2027) |
| KEYNOTE-017 | Recurrent / metastatic Merkel cell carcinoma | Approved | 56% ORR · 1L advanced MCC (KN-017) | · | 2018-12-19 | not itemised | not itemised | not itemised | $28.9M (2022) |
| KEYNOTE-170 | Refractory / relapsed primary mediastinal large B-cell lymphoma | Approved | ~45% · ORR (KEYNOTE-170) | · | 2018-06-13 | not itemised | not itemised | not itemised | $26.7M (2024) |
| KEYNOTE-224 / -394 | 2L hepatocellular carcinoma (post-sorafenib) | Approved | ORR ~17% · Response (KN-224, post-sorafenib) | · | 2018-11-09 | not itemised | not itemised | not itemised | $171M (2025) |
| KEYNOTE-048 | 1L head & neck SCC | Approved | HR 0.61 · OS benefit (mono, CPS≥20) | · | 2019-06-10 | 2019-11-20 | not itemised | not itemised | $1.97B (2025) |
| KEYNOTE-146 / -775 | Advanced endometrial carcinoma, pMMR / not MSI-H, after prior systemic therapy (with lenvatinib) | Approved | - | · | 2021-07-21 | not itemised | not itemised | not itemised | In cockpit → |
| KEYNOTE-426 | 1L advanced renal cell carcinoma, + axitinib | Approved | - | · | 2019-04-19 | 2019-09-04 | not itemised | not itemised | In cockpit → |
| KEYNOTE-177 | 1L MSI-H / dMMR colorectal cancer | Approved | 16.5 mo · PFS (vs 8.2 mo chemo) | · | 2020-06-29 | 2021-01-26 | not itemised | not itemised | $607M (2026) |
| KEYNOTE-057 | BCG-unresponsive high-risk NMIBC (CIS) | Approved | CRR 41% · Complete response (3 mo) | · | 2020-01-08 | not itemised | not itemised | not itemised | $295M (2024) |
| KEYNOTE-629 | Recurrent / metastatic cutaneous SCC | Approved | 35.2% · ORR (R/M cohort) | · | 2020-06-24 | not itemised | not itemised | not itemised | $566M (2027) |
| KEYNOTE-522 / -355 | Early & metastatic TNBC | Approved | HR 0.66 · OS benefit (KN-522 early) | · | 2021-07-26 | 2022-05-24 | not itemised | not itemised | $2.49B (2027) |
| KEYNOTE-811 | 1L HER2+ gastric / GEJ | Approved | HR 0.80 · OS benefit (CPS≥1 0.79) | · | 2021-05-05 | 2023-08-29 | not itemised | not itemised | $684M (2028) |
| KEYNOTE-590 | Esophageal / GEJ carcinoma | Approved | HR 0.73 · OS benefit (all randomised) | · | 2021-03-22 | 2021-06-29 | not itemised | not itemised | $840M (2025) |
| KEYNOTE-564 | Adjuvant renal cell carcinoma | Approved | HR 0.72 · DFS benefit | · | 2021-11-17 | 2022-01-27 | not itemised | not itemised | $1.30B (2027) |
| KEYNOTE-671 | Perioperative / neoadjuvant NSCLC | Approved | HR 0.58 · EFS benefit | · | 2023-10-16 | 2024-03-28 | not itemised | not itemised | $1.58B (2029) |
| KEYNOTE-091 | Adjuvant resected NSCLC (stage IB–IIIA) | Approved | HR 0.73 · DFS benefit (overall) | · | 2023-01-26 | 2023-10-16 | not itemised | not itemised | $853M (2026) |
| KEYNOTE-A39 / EV-302 | 1L urothelial carcinoma, + enfortumab vedotin | Approved | HR 0.47 · OS benefit | · | 2023-12-15 | 2024-09-03 | not itemised | not itemised | $1.55B (2029) |
| KEYNOTE-966 | Biliary tract cancer, + gemcitabine / cisplatin | Approved | HR 0.83 · OS benefit | · | 2023-10-31 | 2023-12-18 | not itemised | not itemised | $260M (2026) |
| KEYNOTE-859 | 1L HER2-negative gastric / GEJ adenocarcinoma, + chemo | Approved | OS HR 0.78 · Overall survival benefit | · | 2023-11-16 | 2023-12-18 | not itemised | not itemised | $348M (2027) |
| KEYNOTE-868 / NRG-GY018 | Endometrial carcinoma | Approved | HR 0.30 · PFS benefit (dMMR) | · | 2024-06-17 | 2024-10-24 | not itemised | not itemised | $893M (2028) |
| KEYNOTE-A18 | Locally advanced cervical + chemoradiation | Approved | - model shared with Cervical, 1L + chemo … | · | 2024-01-12 | 2024-10-24 | not itemised | not itemised | In cockpit → |
| KEYNOTE-689 | Perioperative HNSCC, OS confirmatory maturation (approved on EFS Jun 2025) | Approved | HR 0.70 · EFS benefit (CPS≥1) | 2026 | 2025-06-12 | 2025-10-29 | not itemised | not itemised | $493M (2033) |
| 3475A-D77 (NCT05722015) | Subcutaneous pembrolizumab (Keytruda Qlex, all indications) | Approved | - model shared with 1L metastatic NSCLC (… | US/EU approved 2025-2026 | 2025-09-19 | 2025-11-19 | not itemised | not itemised | In cockpit → |
| KEYNOTE-905 | Perioperative cisplatin-ineligible MIBC (+ Padcev) | Approved | HR 0.40 · EFS benefit (EV+pembro) | FDA approved 2025 | 2025-11-21 | 2026-06-24 | not itemised | not itemised | $250M (2029) |
| KEYNOTE-B15/EV-304 | Perioperative cisplatin-eligible muscle-invasive bladder cancer (neoadjuvant + adjuvant, with enfortumab vedotin) | Approved | EFS HR 0.53 · vs neoadjuvant gem/cis | · | 2026-07-10 | not itemised | not itemised | not itemised | $407M (2033) |
| KEYNOTE-D19/ASCENT-04 | 1L PD-L1+ (CPS>=10) advanced triple-negative breast cancer (with sacituzumab govitecan) | Approved | - model shared with Early & metastatic TN… | 2026 | 2026-06-24 | not itemised | not itemised | not itemised | In cockpit → |
| KEYNOTE-B96/ENGOT-ov65 | Platinum-resistant recurrent ovarian cancer (with paclitaxel +/- bevacizumab) | Approved | HR 0.70 · PFS benefit (all-comers) | 2026 | 2026-02-10 | 2026-04-02 | not itemised | not itemised | $203M (2029) |
| MK-3475A-F84 | 1L metastatic NSCLC PD-L1 TPS>=50%, SC monotherapy | Phase III | Phase III ongoing | - | n/r | n/r | n/r | n/r | In cockpit → |
| KEYNOTE-676 | High-risk non-muscle-invasive bladder cancer, BCG-naive and post-BCG (with BCG) | Phase III | Phase III ongoing | 2027 | n/r | n/r | n/r | n/r | $467M (2031) |
| KEYNOTE-992 | Muscle-invasive bladder cancer, bladder-preservation chemoradiation | Phase III | Phase III ongoing | ~2027 | n/r | n/r | n/r | n/r | $148M (2031) |
| INTerpath-001 | Adjuvant resected high-risk melanoma stage IIB-IV (with V940/intismeran autogene) | Phase III | Phase III ongoing | 2029 | n/r | n/r | n/r | n/r | $1.08B (2033) |
| KEYLYNK-012 | Unresectable stage III NSCLC, concurrent chemoradiation (with/without olaparib) | Phase III | Phase III ongoing | 2027 | n/r | n/r | n/r | n/r | $439M (2030) |
| KEYLYNK-013 | Limited-stage SCLC, concurrent chemoradiation (with/without olaparib) | Phase III | Phase III ongoing | 2027 | n/r | n/r | n/r | n/r | In cockpit → |
| KEYNOTE-975 | 1L locally advanced unresectable esophageal carcinoma, definitive chemoradiation | Phase III | Phase III ongoing | 2026 - EFS MISSED | n/r | n/r | n/r | n/r | In cockpit → |
| KEYNOTE-756 | High-risk early-stage ER+/HER2- breast cancer, neoadjuvant + adjuvant | Phase III | Phase III ongoing | 2026 | n/r | n/r | n/r | n/r | $1.13B (2032) |
Region columns show confirmed approval dates only. Est. peak is a model estimate, not a reported figure.
Provenance
Safety is not the constraint on this asset; competition and label breadth are.
For the largest oncology franchise in the industry the label is strikingly clean at the front page: no boxed warning, no REMS, no contraindications, and every risk held as a Warning & Precaution. Nothing in §5.1-5.5 gates access in the settings that carry the revenue. Two label facts do shape where the franchise can grow: pneumonitis rises with prior thoracic radiation, which is the toxicity to watch as pembrolizumab pushes into concurrent-chemoradiation settings, and §5.4 closes multiple myeloma outright on a mortality finding rather than a tolerability one.
Ormeval viewSafety is not the constraint on this asset; competition and label breadth are. The one place it becomes commercially decisive is thoracic: any Stage III or limited-stage chemoradiation strategy is judged on the pneumonitis rate as much as on efficacy, and the label already concedes the gradient. The subcutaneous co-formulation changes administration burden and infusion-chair economics, not the underlying immune-mediated profile - its §5.2 is the same reaction risk under a different heading.
Single-trial, arm-by-arm rates live on the indication pages: KEYNOTE-189 / -407 / -024: 1L metastatic NSCLC, arm-by-arm →
Boxed warning
None
label 10 Jul 2026
None - verified on the current USPI (KEYTRUDA, effective 10 Jul 2026) and on KEYTRUDA QLEX (effective 31 Jul 2026); neither label carries one
REMS
None
label 10 Jul 2026
None - no REMS appears on either the IV or the subcutaneous label
Contraindications
None
§4 · label 10 Jul 2026
None listed (§4)
Use restrictions
1 stated
§5.4 · label 10 Jul 2026
Not recommended in multiple myeloma with a thalidomide analogue plus dexamethasone outside controlled trials (§5.4)
Pregnancy
Fetal harm
label 10 Jul 2026
Can cause fetal harm; effective contraception during treatment and for 4 months after the last dose
Bands are qualitative frequency categories, not rates we computed. Where the label states a single pooled incidence it is quoted verbatim in the note and the band follows the conventional frequency convention applied to that figure. Pembrolizumab's Warnings & Precautions rates come from one specific 2,799-patient single-agent safety pool; the label separately reports much higher setting-specific rates (for example hypothyroidism 22% in adjuvant resected NSCLC), and combination regimens carry their partner's toxicity on top. Nothing here is averaged across those pools.
No notes for this section.
| What | When | Label section |
|---|---|---|
| Baseline and periodic labs | Liver enzymes, creatinine and thyroid function at baseline and periodically during treatment; in TNBC treated in the neoadjuvant setting, blood cortisol at baseline, before surgery and as clinically indicated. | · |
| Corticosteroids | If treatment requires interruption or discontinuation, prednisone 1-2 mg/kg/day or equivalent until improvement to Grade 1 or less, then taper over at least 1 month. Endocrinopathies and dermatologic reactions have their own guidance and do not necessarily require systemic steroids. | · |
| Hold | Withhold for most Grade 2-3 immune-mediated reactions until resolution, per the severity table in §2.3. | §2.3 |
| Discontinue | Permanently discontinue for Grade 3-4 (or recurrent Grade 3) reactions per §2.3, and for Grade 3-4 infusion-related reactions. | §2.3 |
| Refractory disease | Consider other systemic immunosuppressants where corticosteroids do not control the reaction; in refractory colitis, repeat the infectious work-up for CMV first. | · |
The synthesis across all indications. Editorial, grounded in the cited trial, guideline and access facts above.
What it shows. The franchise-level synthesis across all of the asset's indications, where the clinical, commercial, access and competitive reads net out.
What to look for. Whether the threats are asset-wide (loss of exclusivity, a class-wide rival) or specific to one indication, the asset-wide ones move the whole investment case.
Common misread. It's a running list, not a fixed verdict; each threat has catalysts that will resolve it, tracked on the catalyst calendar.
This SWOT is synthesised from the cited pivotal-trial readouts and the company’s investor-relations filings referenced in the badges above. Each point nets the relevant clinical, commercial and competitive evidence into a single franchise-level read; the tags identify the anchoring trial or source behind the underlying data.
Other tracked Merck & Co. franchises, sorted by reported revenue. Each links to its own asset page.
| Product | Therapy area | Trajectory | Revenue | YoY | QoQ | US LOE | Approved | Pipeline |
|---|---|---|---|---|---|---|---|---|
| Gardasil / Gardasil 9 | Vaccines & Infectious | $5.23BFY25 | −$3.35B▼ 39% vs FY24 | $1.17B▲ 9% vs Q1 2026 | ~2025lapsed | 1 | 0 | |
| Januvia / Janumet | Cardiovascular & Metabolic | $2.54BFY25 | +$276M▲ 12% vs FY24 | $429M▼ 25% vs Q1 2026 | ~2026 | 1 | 0 | |
| Bridion | Neuroscience | $1.84BFY25 | +$77.0M▲ 4% vs FY24 | $497M▲ 5% vs Q1 2026 | ~2026 | 1 | 0 | |
| Winrevair | Cardiovascular & Metabolic | $1.44BFY25 | - | $588M▲ 12% vs Q1 2026 | ~2036 | 2 | 1 | |
| Capvaxive | Vaccines & Infectious | $759MFY25 | - | $184M▲ 30% vs Q1 2026 | ~2035 | 3 | 0 |
Every reported figure on this page traces to one of the public sources below. Forward figures are model estimates and are labelled as such.Sourced · as of Q2 2026
Reported figures are public facts transcribed from company investor materials and SEC filings. The outlook curve, modelled peak and loss-of-exclusivity timing are flagged Ormeval model projections, not analyst consensus. For decision-support only: not investment, financial, or medical advice. Follow this asset to build an editable, deterministic forecast around these anchors.