Ormeval provides decision-support intelligence derived from public sources. It is not investment, medical, legal or regulatory advice, and states nothing about the value of any security. Forward figures are deterministic model estimates, not guidance.
Keytruda (pembrolizumab) · anti-PD-1 + chemo · Merck & Co.
This page covers 1L advanced/recurrent endometrial carcinoma (KEYNOTE-868/NRG-GY018, all-comers), not the later-line dMMR monotherapy (KEYNOTE-158) or pembro+lenvatinib (KEYNOTE-775) settings, nor non-endometrial Keytruda indications. See all Keytruda indications →
Verified on label; year correct, date added. Label 1.17: 'in combination with carboplatin and paclitaxel, followed by KEYTRUDA as a single agent, for the treatment of adult patients with primary advanced or recurrent endometrial carcinoma.' Approved 2024-06-17 on KEYNOTE-868/NRG-GY018. Important scope point: this indication is all-comers by mismatch-repair status - it is NOT restricted to dMMR/MSI-H. It should not be conflated with the two OTHER endometrial indications already on the label from earlier actions: the lenvatinib combination for pMMR/not-MSI-H disease after prior systemic therapy (AA 2019-09-17, converted 2021-07-21) and single-agent pembrolizumab for MSI-H/dMMR disease after prior therapy. Adults only. Traditional approval.
All markets
2026 net revenue · modelled, early ramp
$595M
CONCLUDED · 2026 modelled net revenue - indication slice, all markets; Merck & Co. reports no indication revenue. Modelled scenario · assumes approval · not guidance
No model change since the 20 Sep 2026 snapshot.
The 15-second read
This is a rising Keytruda slice that runs straight into the franchise cliff before it finishes ramping: the all-comers 1L approval only landed in June 2024, the line reaches $595M in 2026 and peaks at $893M in 2028, the same year US composition-of-matter protection lapses, then falls to $597M by 2030 and flattens near $515M. Two things decide it. First, share: dostarlimab (Jemperli, RUBY) won a co-equal NCCN Category 1 all-comers 1L position the same year with a more mature OS dataset, so this is a genuinely contested race, not a monopoly. Second, timing: the underlying pool is genuinely growing (obesity-driven endometrial incidence at ~+1.5%/yr), but biosimilars arrive mid-ramp and take the growth with them. The honest read is that the KEYNOTE-868 PFS data are strong (dMMR HR 0.30, pMMR HR 0.54) but OS is still immature in both cohorts, and the pMMR majority is where the benefit is smaller.
Threats land:If the immature OS never reaches significance in pMMR (currently HR 0.79) while dostarlimab's mature RUBY OS advantage holds, prescribers consolidate on Jemperli and pembrolizumab never reaches the modelled $893M peak before biosimilars hit.
Modelled path:Uptake keeps building across the eight markets through 2028 into a shared 1L IO market, the line peaks at $893M, then US biosimilars from ~2028 and EU from ~2029 pull it to a ~$515M plateau with SC Qlex defending part of the volume.
Levers land:Rising incidence, pending Japan and China approvals and Keytruda Qlex conversion hold volume through the biosimilar wave, keeping the post-2030 plateau materially above $597M.
The 1L-systemic-eligible fraction of incident endometrial cancer, an Ormeval scoping estimate of ~15-20% (de-novo Stage III/IV plus recurrence, since most endometrial cancer is early-stage and cured surgically), explicitly sensitised across 0.13-0.22, which sets the denominator for the entire slice.
At a glance
Mechanism anti-PD-1 + chemo
Clinical
Commercial
Development to approval
These are regulatory approval dates (FDA/EMA/NMPA/PMDA), not commercial launch; launch follows after pricing & reimbursement (see the access-lag column in the HTA table). All four regulators have approved this indication. Cross-checked against Merck & Co. disclosures and regulator databases.
1L advanced/recurrent endometrial carcinoma carried Keytruda into front-line gynaecologic oncology with a broad all-comers label, and is a RISING growth slice riding a cancer whose incidence is climbing. At a ~$0.9B modelled peak it is a meaningful mid-sized franchise line, strategically valuable as a counterweight to the eroding mature lung settings. Its principal strategic challenge is share: dostarlimab (RUBY) won an all-comers 1L approval the same year and has more mature OS data, so this is a genuinely contested 1L IO race rather than a monopoly.
Advanced/recurrent endometrial carcinoma, the most common gynaecologic cancer, with rising obesity-driven incidence, was a carboplatin/paclitaxel setting until IO. KEYNOTE-868/NRG-GY018 added pembrolizumab with striking PFS benefit (dMMR HR 0.30; pMMR HR 0.54), driving a broad 1L all-comers approval (Jun 2024). It is a RISING slice (~$0.9B modelled peak) ramping from the 2024 launch, contested by dostarlimab (RUBY), the key IO rival, and durvalumab (DUO-E).
Endometrial (uterine corpus) carcinoma is the most common gynaecologic malignancy and one of the few cancers with RISING incidence (obesity-driven). Most is diagnosed early and cured by surgery; the 1L-systemic-eligible pool is the de-novo Stage III/IV plus recurrent disease (~15-20% of incident cases). Treatment is stratified by mismatch-repair (MMR) status: dMMR/MSI-H (~25-30%) derives the largest IO benefit (PFS HR 0.30), while pMMR (~70-75%) still benefits (HR 0.54), and the Jun 2024 all-comers label makes the ENTIRE advanced pool addressable. Across the 8 modelled markets the 1L-eligible advanced/recurrent endometrial pool is sized from corpus-uteri incidence × the advanced/recurrent fraction.
KEYNOTE-868 (NRG-GY018) added pembrolizumab to carboplatin/paclitaxel in 1L advanced/recurrent endometrial cancer, with dramatic PFS benefit in the mismatch-repair-deficient cohort (HR 0.30) and a strong benefit in the mismatch-repair-proficient cohort (HR 0.54), driving a broad all-comers FDA approval (Jun 2024) regardless of MMR status. It moved IO into the 1L endometrial setting and is a rising franchise slice.
MMR/MSI testing stratifies benefit (dMMR > pMMR) but the Jun 2024 all-comers label means the entire advanced/recurrent pool is addressable. The 1L-eligible pool is de-novo Stage III/IV plus recurrence (~15-20% of incident EC); dostarlimab is co-listed Category 1.
Phase 3 randomized double-blind placebo-controlled (n=816; NRG Oncology / Merck): measurable Stage III/IVA or Stage IVB/recurrent endometrial carcinoma, pembrolizumab (or placebo) + carboplatin/paclitaxel × 6 cycles then pembrolizumab maintenance up to ~2 years, in two independent cohorts stratified by MMR status (225 dMMR / 591 pMMR). Primary endpoint investigator-assessed PFS in each cohort.
Load-bearing 4/5 sourced. ASSUMED uptake is yours to change.
RISING INDICATION, broad 1L all-comers approval Jun 2024 (US), EU late 2024. Revenue ramps from the 2024 launch toward a ~$0.9B peak; figures pre-plateau are forward estimates contingent on uptake vs dostarlimab.
This indication only, not Keytruda's total revenue
First-line primary advanced (Stage III/IVA) or recurrent endometrial carcinoma, pembrolizumab + carboplatin/paclitaxel followed by single-agent pembrolizumab maintenance, regardless of mismatch-repair status (KEYNOTE-868 / NRG-GY018). The all-comers regimen is the broad rising indication; the branded Keytruda line is the monetized slice.
Reported actuals are always drawn and need no chip: a cited reported figure is a fact, not a claim. Everything forward of them is one of the 4 kinds above.
$595M
8 modelled markets (US, EU5, JP, CN) · modelled net revenue · 2026 (forecast)
Peak $893M · launch 2024 → 2034
modeled history (left of today)·click any year to decompose its funnel below.
Measured band: none - no measured band: n<8
Bull / bear elsewhere in the product are a sensitivity (fixed multipliers), not this band.
Pre-2026 figures are MODELLED and calibrated to Merck's reported Keytruda franchise (FY2025 ≈ $31.7B): the 1L advanced/recurrent endometrial slice RISES from the 2024 all-comers launch to a ~$0.9B peak around 2031-33 ≈ ~3% of the franchise, a rising slice riding a growing cancer, tempered by a SHARED 1L IO market (dostarlimab co-equal) and the ~2028 LOE arriving mid-ramp. Pre-plateau figures are forward estimates. The 'today' marker splits the brief modelled history from forecast.
No reported anchor exists at this grain: companies publish this asset as one product line and never split it by indication × country, so every year above is modelled, including the years already past. The claims below are scored against reported actuals wherever a program has them.
A forecast year closes when an actual is reported for it. A miss is the distance from that actual, signed as the claim fell: under it, or over it.
| Claim | Closed years | Worst miss | Worst miss % |
|---|---|---|---|
| Ormeval modelMODELLED · Ormeval · live | - | no closed year yet | - |
A superseded team version keeps its own row: what it was off by is still a fact about that version. A row with no closed year is not a good score.
What it shows. A modelled base-case net-revenue curve for this indication, year by year, split at 'today' into modelled history and forecast, with the branded curve shown against its in-class rivals.
What to look for. The peak year and how steep the decline is after loss of exclusivity, and where a rival's curve crosses yours, that crossing is the share the model has you losing.
Common misread. Reading the pre-'today' portion as reported actuals (it's modelled), or treating the base case as a company target. It is one deterministic Ormeval-modelled scenario anchored to cited actuals, not guidance and not analyst consensus.
Key model assumptions · The headline rests on that advanced/recurrent fraction, on branded pembrolizumab's uptake in a market it shares co-equally with dostarlimab, and on per-market net prices against a ~$11.8k US ASP per 200 mg, with China the largest judgment call, where approval timing is assumed (~2026-27) and cheap NRDL-listed domestic PD-1s compress share.
The decline is defended, not certain
The post-2028 decline is defended by a dated, certain event, US pembrolizumab composition-of-matter LOE around 2028 and EU around 2029, but its depth is an estimate, because subcutaneous Keytruda Qlex (FDA-approved Sep 2025) is an untested volume defense and the pace of IV biosimilar substitution in a chemo-combination oncology setting has no direct precedent.
What would change our mind
If dostarlimab's mature RUBY OS advantage translates into clear NCCN or prescriber preference and Jemperli takes the plurality of 1L all-comers starts before 2028, the modelled $813M-to-$893M ramp is too high; equally, any slip in US pembrolizumab biosimilar entry past 2029 makes the post-peak drop mis-dated.
A scenario is your own assumptions layered on Ormeval’s cited baseline. We never change the baseline; save as many named scenarios as you like and click one to load it back later.
| Driver · 2026 | US | FR | DE | IT | ES | UK | JP | CN | Total | Source |
|---|---|---|---|---|---|---|---|---|---|---|
| Endometrial (corpus uteri) cancer incidence (2026) | 70k | 8.4k | 11k | 9.0k | 7.2k | 10.0k | 18k | 87k | 221k | GLOBOCAN 2022 |
New uterine corpus cancer cases per year; +1.5%/yr (rising, obesity-driven). Shown for 2026: 2024 basis +2%/yr → ×1.030. Country-specific GLOBOCAN 2022 corpus-uteri incidence; +1.5%/yr reflects the well-documented obesity-driven rise. Global 2022 corpus-uteri incidence ~420k. | ||||||||||
| × Advanced/recurrent (1L-systemic-eligible)est | 17% | 17% | 17% | 17% | 17% | 17% | 17% | 18% | share, not summed | stage + recurrence |
De-novo Stage III/IV plus recurrent disease, the 1L-systemic-IO-eligible fraction (most EC is early/curable by surgery). Most endometrial cancer is diagnosed early and cured by surgery; the 1L-systemic-eligible pool is de-novo Stage III/IV (~13-20%) plus recurrences → ~17% of incident EC. The key estimate (sensitise 0.13-0.22). | ||||||||||
| × Tested, fit & IO-treatedest | 84% | 82% | 82% | 78% | 78% | 80% | 82% | 55% | share, not summed | MMR testing audits |
MMR/MSI-tested, fit for and receiving 1L pembro+chemo. Branded pembrolizumab UPTAKE (vs dostarlimab) is the share row below. Captures MMR/MSI testing completeness and fitness for 1L chemo-IO (excludes those who get chemo-only/best supportive care or are untested). High in Western academic systems and Japan (~0.80-0.84); lower in China (~0.55, testing/access tier-concentrated). Excludes branded UPTAKE (the dostarlimab-vs-pembro share layer below). | ||||||||||
| = Addressable 1L advanced/recurrent pool | 10k | 1.2k | 1.6k | 1.2k | 966 | 1.4k | 2.6k | 8.7k | 28k | computed |
Corpus-uteri incidence × the rates above, advanced/recurrent endometrial patients reachable for 1L IO + chemo this year. The 1L advanced/recurrent endometrial pool GROWS over the forecast, endometrial incidence is rising (obesity-driven, +1.5%/yr) and MMR-testing completeness is improving, a structural tailwind, unlike the eroding mature lung settings. | ||||||||||
| × Keytruda uptake (branded) | 26% | 16% | 17% | 19% | 9% | 19% | 21% | 0% | share, not summed | ASSUMED |
Per-market branded uptake of the addressable pool this year (launch ramp net of competitors & biosimilars). See the competitive curve below; pick a market for its access basis. | ||||||||||
| = Treated with Keytruda | 2.6k | 193 | 273 | 222 | 89 | 263 | 534 | 0 | 4.2k | computed · assumed input |
Addressable pool × branded uptake. | ||||||||||
| × Net price / patient (2026) | $178K | $86K | $91K | $82K | $77K | $85K | $77K | $29K | per patient, not summed | ASP · HTA · NRDL |
The 1L EC regimen is chemo-IO induction then pembrolizumab maintenance (~2-year cap), modelled at ~one patient-year of net revenue for the pembrolizumab component. US ASP ≈ $11.8k/200mg q3w (~$205k/yr list) net of ~10-15% GTN → ~$185k/yr. EU ~$80-95k. Japan ~$80k. China ~$30k. −2%/yr forward; held flat before 2024. SHOWN FOR 2026: the per-market figures in "Net pricing: assumptions & basis" below are the 2024 basis; this row applies -2%/yr from 2024 (×0.9604), so it is the same source value at a later date, not a second price. | ||||||||||
| = Net revenue / yrOutput | $465M | $16.7M | $24.9M | $18.1M | $6.9M | $22.3M | $41.0M | $0 | $595M | computed · assumed input |
Treated patients × realized net price. | ||||||||||
Regional revenue mix · 2026 modelled
Model estimate, sourced from the funnel table above
No reported competitor-share series exists for this setting, so every trajectory below is modelled from approval timing, label breadth and the funnel, not reported data.
In-class share, 1L advanced/recurrent endometrial: 8 modelled markets (US, EU5, JP, CN)
Each agent's share of the addressable 1L advanced/recurrent pool. The branded-pembrolizumab line ramps from the 2024 all-comers launch into a SHARED 1L IO market (dostarlimab co-equal), then meets the ~2028 LOE biosimilar erosion; the gap below the top line is patients on chemo-only or dostarlimab/durvalumab. The branded pembrolizumab line (IV + SC Qlex) is the only line this model monetizes.
Share of the 28k-patient addressable 1L advanced/recurrent pool this regimen is modelled to treat, by year
Keytruda is modelled at 15% of this pool in 2026, peaking at 26% in 2028; each point of share is revenue on the chart above.
Scope: 8 modelled markets (US, EU5, JP, CN) · follows the market selector above
Rivals' share, same pool
Dostarlimab (Jemperli) holds the largest rival share in 2026, 6% of the pool; that is the share Keytruda has to take or hold.
Rivals, rescaled - note the axis maximum (20%), which is smaller than the plot above. Same data, a linear axis of its own, so a low-share entrant is readable rather than a hairline on the baseline.
Uptake ramp = approval/reimbursement timing (US all-comers Jun 2024, EU late 2024, ex-US 2025-27) into a market SHARED with dostarlimab (RUBY, co-equal 1L) and durvalumab (DUO-E); domestic Chinese PD-1s take China-only share; pembrolizumab biosimilars timed to the ~2028 US / ~2029 EU LOE. Competitor trajectories are stated assumptions.
Readouts, approvals and LOE events for pembrolizumab and its rivals in this setting. Estimated timing is flagged; confirmed dates cited from Merck & Co. disclosures and regulator databases.
Composition-of-matter expiry (~2028) arrives during the ramp; biosimilars erode the branded endometrial line
EU biosimilar entry; SC Qlex conversion mitigates IV-biosimilar share loss
Estimated Japan/China 1L endometrial approvals broaden the addressable base
✓ = reported public fact, cited. Upcoming timing is estimated from company guidance and trial registries, a projection, not a commitment. Approvals = US (FDA) · EU (EMA) · Japan (PMDA) · China (NMPA). ● = pembrolizumab, competitor tag = a same-setting rival.
Residual unmet need: why the field stays alive
Even with 1L pembrolizumab + chemo, most pMMR patients eventually progress (the IO benefit is smaller than in dMMR), OS is still maturing, and there is no established post-1L-IO standard. dMMR patients do well but are the minority; serous and high-grade histologies remain hard to treat. That residual sustains development of antibody-drug conjugates, PARP combinations (DUO-E olaparib arm) and the pembro+lenvatinib combination now shifting to true 2L (post-IO).
The synthesis for this indication, grounded in the cited trial, guideline and access facts above.
Rivals in this setting (1L advanced/recurrent endometrial)
Swipe to explore →
| Rival / regimen | Developer | Position in this setting | Approved (date, trial, n) | Head start vs this regimen (months) | Source |
|---|---|---|---|---|---|
| Dostarlimab (Jemperli) (Live threat) | GSK | Live threatwhyTHE key IO competitor, co-equal NCCN Category 1, all-comers 1L (dMMR Jul 2023, all-comers Aug 2024), with a more mature OS dataset (RUBY OS 44.6 vs 28.2 mo overall). A genuine share rival. | not in the record | not in the record | RUBY, dostarlimab + chemo 1L endometrial (Mirza, NEJM 2023) |
| Durvalumab (Imfinzi, DUO-E) (Watch) | AstraZeneca | WatchwhyThird 1L IO entrant, approved for dMMR (and a pMMR + olaparib maintenance arm); narrower positioning than the all-comers pembro/dostarlimab regimens. | not in the record | not in the record | DUO-E |
| Carboplatin/paclitaxel (backbone) (Pool erosion) | Generic | Pool erosionwhyThe prior 1L standard and chemo backbone the IO is added to; the residual for patients not on an IO regimen. | not in the record | not in the record | - |
| Pembro + lenvatinib (KEYNOTE-775, intra-franchise) (Merck & Co. pipeline) | Merck / Eisai | Merck & Co. pipelinewhyMerck's own combo, now shifting to true 2L (post-1L-IO) as IO moves front-line, an intra-franchise sequencing dynamic, not a 1L rival here. | not in the record | not in the record | pembrolizumab LOE ~2028 (US) |
| Domestic Chinese PD-1s (China rival) | Innovent / Hengrui / others | China rivalwhyNRDL-listed, far cheaper, structural China 1L EC share pressure for branded Keytruda. | not in the record | not in the record | NMPA / NRDL |
| Keytruda Qlex (subcutaneous) (Merck & Co. pipeline) | Merck | Merck & Co. pipelinewhyFDA-approved Sep 2025, intra-brand LOE/convenience defense (monetized within the branded line). | Sep 2025, - | -15 (after) | Keytruda Qlex (subcutaneous) FDA approval (Merck, Sep 2025) |
Not every rival is approved in every region, so a share here is the modelled position in the markets where it competes, not a global one.
Net pricing: assumptions & basis
The 1L endometrial regimen is pembrolizumab + carbo/paclitaxel then pembrolizumab maintenance (up to ~2 years), so per-patient revenue is ~one patient-year of net for the pembrolizumab component (chemo separate). US ASP ~$11.8k per 200 mg; net prices below are per-market.
Figures below are 2024 net prices, the basis the model is anchored on. The funnel applies -2%/yr from 2024, so the price it consumes for a later year is lower than the figure quoted here. Both come from this one value; the funnel row states the year it is showing.
Pembrolizumab is given with carboplatin/paclitaxel for 6 cycles then as maintenance up to ~2 years, so per-patient revenue is modelled as ~one patient-year of net for the pembrolizumab component (the chemo is separate spend). US ASP ≈ $11,795/200 mg q3w (~$205k/yr list) ⇒ ~$185k/yr net after ~10-15% GTN. EU nets HTA-negotiated (~$80-95k). Japan NHI ~$80k. China access ~$30k. −2%/yr forward; held flat before 2024. ALL net prices are ESTIMATES.
What it shows. The approval-to-reimbursement journey by market: when each payer granted access, on what terms (PD-L1 or comparator restrictions), and the lag between regulatory approval and reimbursed revenue.
What to look for. The access-lag column, approval is not revenue and some markets take a year or more. And the restrictions that narrow the eligible population below the full label.
Common misread. Assuming a US price or approval transfers to other markets. Ex-US payers benchmark against comparators and reference prices, so the net price and the covered population are usually smaller.
Rows ordered by access speed. The approval→reimbursement lag is commercially load-bearing, and it is not one number per drug: a monotherapy indication and a later combination extension file separately with a payer and can reach routine commissioning years apart, even within the same asset’s first-line setting.
| Market | HTA body | Decision | Access lag | PD-L1 | Comparator | Key outcome / MEA note |
|---|---|---|---|---|---|---|
| US | FDA | 17 Jun 2024 (all-comers 1L) | reference | all-comers (MMR-agnostic) | Carboplatin/paclitaxel | Medicare/commercial; ramp from launch; ~10-15% gross-to-net |
| Germany | G-BA / IQWiG | ~2025 | ~0.5 yr | all-comers | Carbo/paclitaxel | EC approval late 2024; AMNOG dossier; densest EU access |
| France | HAS | ~2025 | ~0.7 yr | all-comers | Carbo/paclitaxel | Early access then reimbursement post-EC; SMR important |
| UK | NICE | ~2025-26 | ~1.5 yr | all-comers | Carbo/paclitaxel | NICE appraisal; confidential PAS; dostarlimab also appraised |
| Italy | AIFA | ~2025-26 | ~1.5 yr | all-comers | Carbo/paclitaxel | Class H; managed entry; +regional formulary lag |
| Spain | SEFH / MoH | ~2026 | ~2 yr | all-comers | Carbo/paclitaxel | Financed; +17-region formulary lag |
| Japan | PMDA / NHI | ~2025 (est., pending) | ~0.5 yr | all-comers (est.) | Carbo/paclitaxel | GY018 enrolled Japanese sites; 1L EC-chemo approval status pending, modelled as a 2025 assumption |
| China | NMPA / NRDL | ~2026-27 (est., pending) | ~2 yr | all-comers (est.) | Carbo/paclitaxel / domestic PD-1 | 1L EC IO market still developing; later access; cheaper domestic PD-1 competition |
How much each assumption could move the forecast, one at a time, over the same cited baseline.
This is a sensitivity illustration, not a probability: it shows how far each assumption could move the forecast, never how likely it is.
Set a target and solve for one lever, what it would have to reach, benchmarked against real comparable launches.
One lever at a time: the other assumptions stay at baseline, so the trade-off stays visible.
A model that shows where its own risk is, not a number to trust. Never investment advice.
Cite this forecast as recorded on Q2 2026 → A permanent record of these figures that does not change when the model does.
Every reported figure here traces to a public source below; the model's own assumptions are labelled where they appear.
Reported figures are public facts from company filings; the forward peak is Ormeval's own modelled estimate, not company guidance and not analyst consensus. Approval and readout dates are cross-checked against public regulator and company disclosures. Not investment advice.