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Keytruda (pembrolizumab) · anti-PD-1 · Merck & Co.
This page covers ONLY the muscle-invasive bladder-cancer bladder-preservation (concurrent-chemoradiation) indication (the KEYNOTE-992 regimen), not the full Keytruda franchise, and NOT the cystectomy/perioperative MIBC setting (that is durvalumab NIAGARA / EV+pembro). See all Keytruda indications →
NCT04241185; pembro + chemoRT vs chemoRT in patients electing bladder preservation.
All markets
Est. peak net revenue · modelled scenario, contingent on positive readout + approval
$148M
CONCLUDED · 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 an option, not an asset: KEYNOTE-992 has not read out (primary completion ~Jan 2027), so the whole curve, zero until 2028, a $148M peak in 2031, $119M by 2034, is contingent on a bladder-intact event-free-survival win nobody has seen. What makes the setting strategically interesting is that it is the one part of the muscle-invasive bladder pathway the perioperative programmes do not touch: NIAGARA and EV+pembrolizumab own the cystectomy route, bladder preservation is unclaimed. What makes it small is that only about 10-20% of MIBC patients choose trimodality therapy, and Roche's atezolizumab trial (SWOG/NRG 1806) tests the identical concept on the identical endpoint and reads out first. Merck is second in line to learn whether the thesis even works.
Threats land:If SWOG/NRG 1806 reads out negative on BI-EFS, the chemoradiation-plus-IO thesis is damaged before KEYNOTE-992 reports and this line stays at zero rather than launching in 2028.
Modelled path:KEYNOTE-992 reads out positive around 2027, launches ~2028 US-first into the bladder-preservation niche and peaks at $148M in 2031 before biosimilar pembrolizumab erodes it.
Levers land:A clear BI-EFS win plus a supportive OS trend shifts more MIBC patients toward organ preservation over cystectomy, expanding the ~10-20% trimodality fraction itself and lifting peak above $148M.
The ~10-18% of muscle-invasive bladder cancer patients modelled as treated with bladder-preservation chemoradiation, explicitly the softest input in the model, an Ormeval scoping estimate varied by market with no reported registry basis.
At a glance
Mechanism anti-PD-1
Clinical
Commercial
Development to approval
This indication is not yet approved: the phases show development stage and regulatory approval is expected, not granted (~2028 (US), contingent on a positive KEYNOTE-992 readout). Per-market timing reflects the company's own guidance (SEC / IR / earnings). Status cross-checked against Merck & Co. disclosures and trial registries.
KEYNOTE-992 would extend Keytruda into the bladder-preservation (organ-sparing) MIBC setting, a niche the perioperative-cystectomy programs (durvalumab NIAGARA; EV + pembrolizumab KEYNOTE-905) do NOT cover, and would give Merck an IO franchise across the full muscle-invasive bladder pathway. Strategically it is a defensible but modest add-on: the addressable pool is small (only the ~10-20% of MIBC on chemoradiation), the pivotal data are not yet public, and the near-identical atezolizumab trial (SWOG/NRG 1806) reads out first and could define the setting or read out negative and cast doubt on the whole chemoradiation-plus-IO thesis. Value is contingent on a positive readout.
Bladder-preservation via trimodality therapy (maximal TURBT + concurrent chemoradiation) is the main organ-sparing alternative to radical cystectomy in muscle-invasive bladder cancer, used in roughly 10-20% of MIBC patients, with excellent outcomes in selected patients but a substantial local-recurrence / salvage-cystectomy rate. KEYNOTE-992 adds pembrolizumab to chemoradiation to improve bladder-intact event-free survival (BICR). The readout is pending (primary completion ~Jan 2027, no results yet), so no efficacy number is asserted; atezolizumab (SWOG/NRG 1806) is testing the identical concept and reads out first.
Muscle-invasive bladder cancer (MIBC) has grown into the bladder muscle wall. The standard curative options are radical cystectomy (bladder removal) or bladder preservation by trimodality therapy, maximal transurethral resection (TURBT) followed by concurrent chemoradiation, which spares the native bladder in ~75-80% of long-term survivors. Only about 10-20% of MIBC patients are treated with bladder-preservation chemoradiation today (the rest go to cystectomy or are unfit for curative therapy), a smaller, well-defined niche. Bladder cancer is the ~9th most common cancer (~614k cases/yr globally), ~25% present muscle-invasive. KEYNOTE-992 addresses the chemoradiation-treated slice specifically; the pool is modest, and pembrolizumab's benefit here is UNPROVEN until the pivotal BI-EFS readout.
KEYNOTE-992 is a Phase 3, randomized, double-blind trial testing whether adding pembrolizumab to concurrent chemoradiotherapy improves bladder-intact event-free survival in muscle-invasive bladder cancer patients pursuing bladder preservation (trimodality therapy). It targets the ~10-20% of MIBC patients who are treated with organ-sparing chemoradiation instead of cystectomy. The pivotal readout is NOT yet public (primary completion estimated Jan 2027, hasResults=false), so no efficacy figure is asserted, this remains a pre-approval scenario, and the direct competitor atezolizumab (SWOG/NRG 1806, same BI-EFS endpoint) reads out first.
Trimodality bladder preservation is an established curative alternative to cystectomy in selected MIBC (~10-20% of patients). Adding pembrolizumab to concurrent chemoradiation is INVESTIGATIONAL, KEYNOTE-992 (pembrolizumab) and SWOG/NRG 1806 (atezolizumab) are the two Ph3 trials testing it, both on a bladder-intact event-free survival endpoint. Neither has reported; no guideline yet endorses concurrent IO + chemoradiation.
Randomized, double-blind, placebo-controlled Ph3 (MK-3475-992); ~520-636 patients randomized 1:1 to concurrent chemoradiotherapy + either pembrolizumab 400 mg IV q6w or placebo, in cT2-T4a N0M0 muscle-invasive bladder cancer (predominant urothelial histology) opting for bladder preservation after maximal TURBT; ECOG 0-2. Chemo = cisplatin, 5-FU/mitomycin C, or gemcitabine (investigator choice); radiotherapy = 64 Gy/32 fx or 55 Gy/20 fx (bladder +/- pelvic nodes). Primary completion estimated Jan 2027.
Pre-approval · Phase III · conditional scenario
This indication is not approved. The revenue below is a modelled scenario that assumes approval and launch around 2028, every input (epidemiology, trial, pricing) is cited, but the approval itself is uncertain. It is an estimate, not guidance and not a reported figure. Read the pivotal-trial and development-timeline sections below for the regulatory basis.
Load-bearing 0/1 sourced. ASSUMED uptake is yours to change.
PRE-APPROVAL SCENARIO. KEYNOTE-992 (NCT04241185) has NOT reported, the pivotal bladder-intact event-free survival readout is pending (primary completion ~Jan 2027) and hasResults is false, so NO efficacy figure is asserted. Revenue is a forward scenario contingent on positive data and approval (estimated US launch ~2028), for the narrow bladder-preservation chemoradiation niche (~10-20% of MIBC). Modelled peak is ~$0.15B. The atezolizumab trial (SWOG/NRG 1806) tests the same concept and reads out first.
This indication only, not Keytruda's total revenue
Pembrolizumab 400 mg IV q6w added concurrently and adjuvantly to definitive chemoradiotherapy (after maximal TURBT), for ~1 year, in patients with muscle-invasive bladder cancer (cT2-T4a N0M0) who opt for bladder preservation rather than radical cystectomy (the KEYNOTE-992 regimen). All-comers by PD-L1.
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.
$0
8 modelled markets (US, EU5, JP, CN) · modelled net revenue · 2026 (forecast)
Peak $148M · launch 2028 → 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.
This is a PRE-APPROVAL scenario. Merck does not (and cannot) report revenue for an unapproved indication, all figures here are a forward model contingent on a positive KEYNOTE-992 readout (pending, ~Jan 2027 primary completion) and an estimated ~2028 launch. Revenue is ~zero before ~2028. The 'today' marker sits in the pre-revenue period.
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 · Two unproven inputs carry the headline: that KEYNOTE-992 reads out positive at all, and the trimodality-eligible fraction it is applied to; per-patient revenue is a modelled ~1-year 400 mg q6w course benchmarked to the NIAGARA MIBC exposure, with no disclosed indication-specific net price.
The decline is defended, not certain
The post-2031 fade rests on pembrolizumab IV biosimilars entering ~2028-2030 and overlapping the launch ramp almost immediately, a dated and defensible driver, though a niche this small could equally be defended by subcutaneous administration or simply never reach the modelled peak.
What would change our mind
If SWOG/NRG 1806 reports a positive BI-EFS result before KEYNOTE-992 and atezolizumab reaches the bladder-preservation setting first, the digest already models it as the earlier entrant, ~2027-28, pembrolizumab enters as the follower and the modelled share of the trimodality pool is too high.
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 |
|---|---|---|---|---|---|---|---|---|---|---|
| Bladder cancer incidence | 85k | 13k | 30k | 29k | 22k | 21k | 23k | 93k | 316k | ACS · GLOBOCAN 2022 |
New bladder-cancer cases/yr; more common in men and in Western/Southern Europe. Bladder cancer is the ~9th most common cancer (~614k/yr globally), ~75% male. Age-standardised rates are highest in Southern/Western Europe (Spain, Italy) and lower in Asia, though China has a large absolute count. ~+0.5%/yr. Same incidence base as the NIAGARA MIBC model. | ||||||||||
| × Muscle-invasiveest | 25% | 25% | 25% | 25% | 25% | 25% | 27% | 30% | share, not summed | literature (~25%) |
Muscle-invasive (vs non-muscle-invasive) at diagnosis. About one-quarter of bladder cancer presents muscle-invasive (the rest is non-muscle-invasive, NMIBC). A consistent ~25% is used across markets, matching the NIAGARA model. | ||||||||||
| × Bladder-preservation chemoradiationest | 14% | 14% | 13% | 13% | 13% | 18% | 11% | 10% | share, not summed | modelled (10-20% lit.) |
Of MIBC, those treated with organ-sparing trimodality therapy (maximal TURBT + concurrent chemoradiation) rather than cystectomy, and fit for concurrent pembrolizumab. Only ~10-20% of MIBC patients are treated with bladder-preservation chemoradiation today (trimodality therapy is underutilized; the majority go to radical cystectomy or are untreated). Modelled per-market: higher in the UK (~18%, strong RT tradition), moderate in the US/EU (~13-15%), lower in Japan/China (~10-12%). The single softest input; flagged estimated. | ||||||||||
| = Addressable bladder-preservation pool | 3.0k | 455 | 975 | 943 | 715 | 945 | 683 | 2.8k | 10k | computed |
Incidence × the rates above, MIBC patients treated with bladder-preservation chemoradiation (trimodality therapy) and fit for concurrent pembrolizumab this year (all-comers by PD-L1). Pre-approval: NO revenue until an estimated ~2028 launch, contingent on a positive readout. China's pool is shown but NOT addressable. Bladder-cancer incidence is roughly stable-to-rising; the mild forward drift up reflects growing interest in organ-sparing therapy (bladder preservation gaining share of MIBC treatment) rather than a shrinking pool. | ||||||||||
| × Keytruda uptake (branded) | 0% | 0% | 0% | 0% | 0% | 0% | 0% | 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 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | computed · assumed input |
Addressable pool × branded uptake. | ||||||||||
| × Net price / patient | $165K | $74K | $81K | $100K | $37K | $94K | $63K | $48K | per patient, not summed | derived (course-adj.) |
Pembrolizumab is dosed 400 mg IV q6w for ~1 year (~8-9 infusions) added to the chemoradiation backbone. Per-patient net revenue is modelled from each market's published Keytruda per-dose net × the ~1-year course, at a level comparable to the durvalumab NIAGARA MIBC course (same disease, same ~1-year IO exposure). −4%/yr forward; flagged modelled, no indication-specific net price is disclosed. | ||||||||||
| = Net revenue / yrOutput | $0 | $0 | $0 | $0 | $0 | $0 | $0 | $0 | $0 | 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, IO + chemoradiation in bladder-preservation MIBC (scenario): 8 modelled markets (US, EU5, JP, CN)
Each agent's share of the addressable bladder-preservation pool (MIBC on trimodality chemoradiation). Pembrolizumab (KEYNOTE-992) is modelled to launch ~2028 IF the readout is positive, then ramp; atezolizumab (SWOG/NRG 1806) is modelled as a co-entrant reaching the niche first (~2027-28). The large gap below the lines is bladder-preservation patients on chemoradiation ALONE (no IO), the current standard. All trajectories are pre-approval assumptions, not reported shares.
Share of the 10k-patient addressable bladder-preservation pool this regimen is modelled to treat, by year
Keytruda is modelled at 0% of this pool in 2026, peaking at 14% in 2031; 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
Atezolizumab + chemoradiation (SWOG/NRG 1806) holds the largest rival share in 2026, 0% 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.
Launch timing = estimated per-market approval, contingent on a positive KEYNOTE-992 readout (US ~2028, EU/Japan/UK ~2029). Atezolizumab (SWOG/NRG 1806) modelled as a co-entrant/first-mover in the same niche. NO efficacy or share data are reported yet; every trajectory is a stated forward assumption. Pembrolizumab biosimilars ~2028-2030 cap the branded window.
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.
Pivotal bladder-intact event-free survival readout (primary completion estimated Jan 2027); the pivotal, currently-unreported event, positive result would enable filing
Estimated US approval / launch, CONTINGENT on a positive readout (all figures are a forward scenario)
The atezolizumab + chemoradiation readout, defines the setting first and directly bears on KEYNOTE-992's prospects
✓ = 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 trimodality therapy, a meaningful share of bladder-preservation patients suffer local muscle-invasive recurrence and require salvage cystectomy, the event that adding pembrolizumab aims to prevent. Whether concurrent IO plus chemoradiation actually improves bladder-intact survival is the central open question, unproven until KEYNOTE-992 (and the parallel atezolizumab SWOG/NRG 1806) report; the setting's small size and the lack of mature data keep it uncertain.
The synthesis for this indication, grounded in the cited trial, guideline and access facts above.
Rivals in this setting (MIBC bladder-preservation (chemoradiation))
Swipe to explore →
| Rival / regimen | Developer | Position in this setting | Approved (date, trial, n) | Head start vs this regimen (months) | Source |
|---|---|---|---|---|---|
| Atezolizumab + chemoradiation (SWOG/NRG 1806, INTACT) (Live threat) | Roche / SWOG-NRG | Live threatwhyThe DIRECT rival, same bladder-preservation concept and same BI-EFS primary endpoint; ~432 patients, closed to accrual Apr 2024, expected to read out AHEAD of KEYNOTE-992. Result not yet public. | not in the record | not in the record | SWOG/NRG 1806 (INTACT), atezolizumab + chemoradiation, same BI-EFS endpoint (NCT03775265) |
| Durvalumab perioperative (NIAGARA) (Pool erosion) | AstraZeneca | Pool erosionwhyAdjacent MIBC setting (cisplatin-eligible cystectomy, not bladder preservation); OS-positive (HR 0.75), pulls patients toward surgery-based IO rather than organ preservation. | not in the record | not in the record | NIAGARA |
| Enfortumab vedotin + pembrolizumab (KEYNOTE-905 / EV-303/304) (Pool erosion) | Astellas/Pfizer + Merck | Pool erosionwhyAdjacent perioperative-cystectomy MIBC (approved cisplatin-ineligible Nov 2025; EV-304 positive Dec 2025); a Merck-partnered regimen competing for MIBC patients earlier in the pathway. | Nov 2025, KEYNOTE-905 / EV-303/304 | not in the record | KEYNOTE-905 / EV-303/304 |
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
Pembrolizumab is given as a ~1-year course of 400 mg IV every 6 weeks (~8-9 infusions) added to concurrent chemoradiation. Per-patient revenue is modelled from each market's published Keytruda per-dose net × the ~1-year course, benchmarked to the durvalumab NIAGARA MIBC course (same disease, same ~1-year IO exposure).
Figures below are 2026 net prices, the basis the model is anchored on. The funnel applies -4%/yr from 2026, 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.
KEYNOTE-992 layers pembrolizumab 400 mg q6w for ~1 year onto trimodality chemoradiation (~8-9 infusions), so realized exposure is modelled at a level comparable to the NIAGARA MIBC course: US ~$165k, France ~$74k, Germany ~$81k (AMNOG), Italy ~$100k, Spain ~$37k, UK ~$94k (PAS), Japan ~$63k. China is not in the base case (pre-approval, no filing signalled). All figures are modelled: no indication-specific net price is publicly disclosed, and all revenue is contingent on a positive readout and approval.
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 | Pre-approval (est. ~2028) | reference | None (all-comers) | Chemoradiation + placebo | Filing contingent on a positive KEYNOTE-992 BI-EFS readout (primary completion ~Jan 2027); estimated approval ~2028. Medicare Part B if approved |
| EU | EMA / EC | Pre-approval (est. ~2029) | ~1 yr | None | Chemoradiation + placebo | Estimated ~2029 if the readout is positive; timing follows a US filing |
| Japan | PMDA / NHI | Pre-approval (est. ~2029) | ~1 yr | None | Chemoradiation + placebo | Estimated ~2029 contingent on positive data; Keytruda has an established Japan oncology presence |
| UK | NICE | Pre-approval (est. ~2029) | ~1 yr | None | Chemoradiation + placebo | Estimated ~2029; NICE appraisal would follow EMA approval. UK has relatively high bladder-preservation uptake |
| France | HAS | Pre-approval (est. ~2029) | ~1 yr | None | Chemoradiation + placebo | Estimated ~2029 if approved; reimbursement position undetermined pre-readout |
| Germany | G-BA / IQWiG | Pre-approval (est. ~2029) | ~1 yr | None | Chemoradiation + placebo | Estimated ~2029; AMNOG benefit assessment would follow. High bladder-cancer incidence market |
| China | NMPA | Pre-approval (est. ~2031+) | n/a | None | - | No bladder-preservation IO filing signalled; modelled as effectively zero (speculative entry ~2031+ only) |
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 material move on this page, newest first, the public fact, and what our model made of it.
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.