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Keytruda (pembrolizumab) · anti-PD-1 · Merck & Co.
This page covers the adjuvant melanoma indication only (KEYNOTE-054 stage III + KEYNOTE-716 stage IIB-IIC), not the 1L advanced (KEYNOTE-006), MSI-H, or non-melanoma Keytruda settings. See all Keytruda indications →
On label; date added, with a staging caveat. Label 1.1: 'for the adjuvant treatment of adult and pediatric (12 years and older) patients with Stage IIB, IIC, or III melanoma following complete resection.' The row's 'stage IIB-III' matches the CURRENT label, but the two stage bands were approved four years apart: KEYNOTE-054 delivered Stage III adjuvant on 2019-02-15 (the date set here), while the Stage IIB/IIC extension came from KEYNOTE-716 on 2021-12-03. A model keyed to the IIB/IIC population should use 2021, not 2019. Note also the paediatric floor of 12 years on this indication - it is one of the few Keytruda indications with an explicit lower age bound. Traditional approval.
All markets
2026 net revenue · modelled adjuvant slice
$1.45B
CONCLUDED · 2026 modelled net revenue - indication slice, all markets; Merck & Co. reports no indication revenue. Modelled net revenue · sourced funnel
No model change since the 20 Sep 2026 snapshot.
The 15-second read
Adjuvant melanoma is a growth slice that has just run out of room to grow. KEYNOTE-054 (stage III, RFS HR 0.57) and KEYNOTE-716 (stage IIB-IIC, RFS HR 0.65) built the indication from $269M in 2019 to a $1.47B peak in 2024, and the model holds it roughly flat through 2027 before the ~2028 US biologic LOE takes it to $596M by 2034. Two features distinguish this from the metastatic Keytruda settings. The course is fixed at up to one year (roughly 17-18 cycles), so per-patient revenue is capped at about one patient-year with no until-progression tail. And the remaining growth lever, stage IIB-IIC uptake, is the hardest sell in the franchise: the number needed to treat is high in node-negative disease, overall survival is not established there, and adjuvant immune toxicity lands on patients who may already be cured. Subcutaneous Qlex, approved September 2025, is the defence, and a fixed-duration adjuvant course is where convenience matters most.
Threats land:The neoadjuvant paradigm displaces pure-adjuvant treatment in resectable high-risk melanoma before the LOE, so pembrolizumab loses adjuvant volume on top of biosimilar erosion and the pre-2028 plateau never holds.
Modelled path:Stage IIB-IIC adoption continues slowly against a high number needed to treat, the slice holds near $1.45B through 2027, and biosimilars (US ~2028, EU ~2029) take it down to roughly $600M by the mid-2030s.
Levers land:Subcutaneous Qlex converts a substantial share of the fixed one-year adjuvant course before IV biosimilars arrive, and ctDNA-guided selection improves the benefit-risk case in stage II enough to lift penetration in the pool's growth segment.
Adjuvant-IO penetration of the resected high-risk pool, built on an estimated resected-high-risk fraction of roughly 24% of incident melanoma in Western markets and ~32% in East Asia, is an Ormeval scoping estimate, and the stage IIB-IIC portion of it is the least settled part, since surveillance rather than treatment remains a common choice there.
At a glance
Mechanism anti-PD-1
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.
Adjuvant melanoma extended pembrolizumab earlier in the disease course and, via KEYNOTE-716, opened the stage IIB-IIC pool, the first adjuvant IO indication in node-negative melanoma, materially enlarging the addressable base. At a ~$1.5B modelled peak it is a growth slice of the franchise that partly substitutes for (and feeds) the 1L advanced setting. Strategically it is a defended growth story: still expanding via stage II uptake, but exposed to the same ~2028 biologic LOE and to adjuvant nivolumab as a direct competitor.
Adjuvant melanoma is the post-surgical treatment of resected high-risk disease to prevent recurrence. KEYNOTE-054 (stage III, RFS HR 0.57; FDA Feb 2019) and KEYNOTE-716 (stage IIB-IIC, RFS HR 0.65; FDA Dec 2021) established adjuvant pembrolizumab as a standard of care, expanding the eligible pool downstage to stage IIB. It is a meaningful growth slice (~$1.5B modelled peak), contested by adjuvant nivolumab (CheckMate-238) and BRAF-targeted adjuvant therapy (COMBI-AT) in BRAF-mutant patients.
Adjuvant therapy treats resected, clinically disease-free but high-recurrence-risk melanoma to delay or prevent relapse. Eligibility spans resected stage IIB-IIC (deep/ulcerated primaries, node-negative) and stage III (node-positive), patients whose 5-year recurrence risk ranges ~25% (IIB) to ~50%+ (IIIC/D). The adjuvant IO options are pembrolizumab and nivolumab (anti-PD-1); BRAF-V600-mutant stage III patients may alternatively receive adjuvant dabrafenib+trametinib (COMBI-AT). Across the 8 modelled markets ~30,000 patients/year are adjuvant-melanoma-eligible, the pool this model sizes, concentrated in fair-skinned Western populations.
KEYNOTE-054 (stage III) and KEYNOTE-716 (stage IIB-IIC) extended pembrolizumab into the adjuvant melanoma setting, reducing recurrence after complete resection of high-risk disease. KEYNOTE-054 showed a recurrence-free survival HR of 0.57 in resected stage III; KEYNOTE-716 was the first phase 3 trial to prove adjuvant benefit in stage IIB/IIC (RFS HR 0.65; distant-metastasis-free survival also improved), opening an entirely new earlier-stage adjuvant pool.
Adjuvant therapy follows complete resection in high-risk patients. Stage IIB-IIC eligibility (KEYNOTE-716) is the newer, still-ramping pool. BRAF V600 testing informs the BRAF-targeted adjuvant alternative for stage III. No PD-L1 gate.
Two randomized, double-blind, placebo-controlled Phase 3 trials. KEYNOTE-054 (EORTC1325; n=1019; resected high-risk stage III; pembrolizumab 200 mg q3w vs placebo for up to 1 year). KEYNOTE-716 (n=976; resected stage IIB-IIC; pembrolizumab 200 mg q3w or pediatric 2 mg/kg vs placebo for up to 1 year). Primary endpoint recurrence-free survival.
Load-bearing 4/5 sourced. ASSUMED uptake is yours to change.
This indication only, not Keytruda's total revenue
Adjuvant pembrolizumab after complete resection of high-risk melanoma, stage III (KEYNOTE-054/EORTC1325) and stage IIB-IIC (KEYNOTE-716), given for up to 1 year to reduce recurrence. 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.
$1.45B
8 modelled markets (US, EU5, JP, CN) · modelled net revenue · 2026 (forecast)
Peak $1.47B · launch 2019 → 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 adjuvant-melanoma slice rises from the 2019 stage III launch, accelerating with the 2021 stage IIB-IIC expansion, to a ~$1.5B peak (~2025), then erodes into the biosimilar cliff, partly defended by SC Qlex. The 'today' marker splits 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 adjuvant-IO penetration split against adjuvant nivolumab and, in the roughly 40-50% BRAF-mutant subset, adjuvant dabrafenib plus trametinib; and on an annual net price for a fixed one-year course derived from a ~$11.8k per 200 mg US ASP (~$205k/yr list), with no indication-level actuals since Merck reports one Keytruda line (FY2025 ≈ $31.7B).
The decline is defended, not certain
The decline is anchored to dated events, US pembrolizumab LOE ~2028 and EU ~2029, but its depth is genuinely uncertain, because subcutaneous Qlex is a real volume defence for a fixed-duration adjuvant course and the model treats biosimilar erosion as gradual rather than cliff-like.
What would change our mind
The base case is wrong if a perioperative or neoadjuvant regimen becomes the NCCN-preferred approach for resectable stage III melanoma before 2028, which would shrink the pure-adjuvant pool ahead of the LOE and make the modelled 2026-27 plateau too high; it is wrong the other way if KEYNOTE-716 reports a positive overall-survival result in stage IIB-IIC, which would move guidelines and reimbursement in the one segment where uptake is still constrained.
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 |
|---|---|---|---|---|---|---|---|---|---|---|
| Melanoma incidence (2026) | 103k | 18k | 34k | 13k | 7.1k | 21k | 4.7k | 8.2k | 210k | GLOBOCAN 2022 |
New cutaneous melanoma cases per year; +1.5%/yr (rising in fair-skinned, ageing populations). Shown for 2026: 2024 basis +2%/yr → ×1.030. Country-specific GLOBOCAN 2022 melanoma incidence (same base as the KEYNOTE-006 1L melanoma model); high in fair-skinned Western populations, far lower in East Asia. +1.5%/yr rising trend. | ||||||||||
| × Resected high-risk (stage IIB-III)est | 24% | 24% | 24% | 24% | 25% | 25% | 32% | 32% | share, not summed | SEER · registries |
Resected stage IIB-IIC + stage III at diagnosis, the adjuvant-eligible high-risk fraction. Adjuvant eligibility combines resected stage III (node-positive, ~11-13% of incident melanoma) and resected stage IIB-IIC (deep/ulcerated node-negative, ~11-13%), together ~24% of incident cases over the disease course (incl. those upstaged at sentinel-node biopsy). Lower-stage I/IIA disease (the majority) is excised and surveilled without adjuvant therapy. Higher in East Asia where later presentation (acral/mucosal) shifts stage up. | ||||||||||
| × Fit for & receiving adjuvant IOest | 62% | 58% | 60% | 55% | 55% | 58% | 45% | 30% | share, not summed | RW adjuvant uptake |
Of resected high-risk patients, those fit for and starting adjuvant anti-PD-1 (excludes surveillance-only, BRAF-targeted-first, frail). Branded pembrolizumab UPTAKE is the share row below. Captures fitness for and receipt of adjuvant anti-PD-1, excluding patients who choose surveillance (common in lower-risk stage IIB), go to BRAF-targeted adjuvant (BRAF-mutant stage III), or are frail. Stage III adoption is high (~0.65-0.7); stage IIB-IIC adoption is lower and still ramping (high NNT, surveillance often preferred), blending to ~0.55-0.62 in the West. Lower in East Asia (smaller pool, access). Excludes pembrolizumab UPTAKE (the share layer below). | ||||||||||
| = Addressable adjuvant-melanoma pool | 15k | 2.6k | 4.9k | 1.7k | 977 | 3.1k | 682 | 791 | 30k | computed |
Incidence × the rates above, resected high-risk melanoma patients reachable for adjuvant anti-PD-1 this year. The adjuvant pool is stable-to-rising, incidence growth (+1.5%/yr) plus expanding stage IIB-IIC adoption (the KEYNOTE-716 ramp, captured in the uptake gate) grow the treated base into the late 2020s. Modelled flat at the pool level; the stage-II growth is in the penetration ramp. | ||||||||||
| × Keytruda uptake (branded) | 38% | 36% | 38% | 35% | 35% | 36% | 33% | 26% | 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 | 5.8k | 926 | 1.8k | 606 | 343 | 1.1k | 227 | 203 | 11k | computed · assumed input |
Addressable pool × branded uptake. | ||||||||||
| × Net price / patient (2026) | $173K | $91K | $96K | $86K | $77K | $85K | $67K | $24K | per patient, not summed | ASP · HTA · NHI |
Fixed 1-year adjuvant course: per-patient revenue is ~one year of net cost (no until-progression tail, unlike the metastatic setting). US ASP ≈ $11.8k/200mg q3w (~$205k/yr list) net of ~10-15% GTN → ~$180k. EU nets ~$80-100k. Japan ~$70k. China ~$25k. −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 | $999M | $84.5M | $177M | $52.4M | $26.3M | $94.6M | $15.2M | $4.9M | $1.45B | 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, adjuvant melanoma immunotherapy: 8 modelled markets (US, EU5, JP, CN)
Each agent's share of the addressable adjuvant pool. The branded-pembrolizumab line shows the launch ramp (stage III 2019, stage IIB-IIC 2021), then the ~2028 LOE erosion; the gap below the top line is patients on adjuvant nivolumab, BRAF-targeted adjuvant, or surveillance. The branded pembrolizumab line (IV + SC Qlex) is the only line this model monetizes.
Share of the 30k-patient addressable adjuvant-melanoma pool this regimen is modelled to treat, by year
Keytruda is modelled at 37% of this pool in 2026, peaking at 37% in 2025; 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
Nivolumab (adjuvant) holds the largest rival share in 2026, 20% of the pool; that is the share Keytruda has to take or hold.
Rivals, rescaled - note the axis maximum (30%), 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 ramp = approval timing (stage III Feb 2019, stage IIB-IIC Dec 2021); adjuvant nivolumab (CheckMate-238) the direct competitor; pembrolizumab biosimilars timed to ~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); pembrolizumab biosimilars erode the branded adjuvant line
EU biosimilar entry; SC Qlex conversion mitigates share loss
✓ = 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 adjuvant anti-PD-1, a substantial minority still recur, KEYNOTE-054 stage III patients have ~36% recurrence by 5 years on pembrolizumab, and stage IIB-IIC benefit, while real, is modest in absolute terms (number-needed-to-treat is high in lower-risk II disease). Adjuvant immune toxicity in otherwise-well patients, no validated biomarker for selection, and uncertainty over OS benefit in stage II keep the setting under active investigation (neoadjuvant approaches, ctDNA-guided therapy).
The synthesis for this indication, grounded in the cited trial, guideline and access facts above.
Rivals in this setting (Adjuvant melanoma (stage IIB-III))
Swipe to explore →
| Rival / regimen | Developer | Position in this setting | Approved (date, trial, n) | Head start vs this regimen (months) | Source |
|---|---|---|---|---|---|
| Nivolumab (adjuvant) (Live threat) | Bristol Myers Squibb | Live threatwhyFDA-approved adjuvant 2017; the direct anti-PD-1 competitor with similar efficacy, co-leads the adjuvant IO setting | not in the record | not in the record | KEYNOTE-054, adjuvant pembrolizumab stage III (Eggermont, NEJM 2018) |
| Dabrafenib + trametinib (adjuvant) (Watch) | Novartis | WatchwhyFDA-approved adjuvant 2018 for BRAF-mutant stage III, an alternative for the ~40-50% BRAF-mutant subset | not in the record | not in the record | KEYNOTE-054, adjuvant pembrolizumab stage III (Eggermont, NEJM 2018) |
| Neoadjuvant anti-PD-1 (paradigm) (Watch) | Multiple | WatchwhyNeoadjuvant/perioperative data could shift practice and reduce pure-adjuvant volume, a structural watch | not in the record | not in the record | SWOG S1801 / NADINA |
| 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, - | -79 (after) | Keytruda Qlex (subcutaneous) FDA approval (Merck, Sep 2025) |
| Pembrolizumab biosimilars (Watch) | Generic (post-LOE) | WatchwhyUS LOE ~2028; EU ~2029, erosion of the branded adjuvant line | not in the record | not in the record | pembrolizumab composition-of-matter LOE ~2028 (US) |
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
Adjuvant pembrolizumab is dosed 200 mg q3w IV (or SC Qlex from Sep 2025) for a fixed up-to-1-year course (~17-18 cycles), so per-patient revenue is ~one year of net cost, with no until-progression tail. US ASP ~$11.8k per 200 mg (~$205k/yr list); 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.
Adjuvant pembrolizumab is a fixed up-to-1-year course (≤18 cycles of 200 mg q3w, IV or SC Qlex), so per-patient revenue is ~one year of net cost, there is no until-progression tail as in the metastatic setting, which caps the per-patient value. US ASP ≈ $11,795/200 mg q3w (~$205k/yr list) ⇒ ~$180k net after ~10-15% GTN. EU nets are HTA-negotiated (~$80-100k). Japan NHI ~$70k. China small/access-limited (~$25k). −2%/yr forward net erosion; 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 | Feb 2019 (stage III) → Dec 2021 (IIB-IIC) | reference | None | Placebo | Medicare Part B (J9271); broad commercial; fixed 1-yr course |
| Germany | G-BA / IQWiG | 2019 → 2022 | ~0.4 yr | None | Placebo | Reimbursed at launch; AMNOG net below list; densest EU access |
| UK | NICE TA766 / TA837 | 2022 | ~1 yr | None | Routine surveillance | Recommended adjuvant stage IIB-III; confidential PAS |
| France | HAS | 2019 → 2022 | ~0.7 yr | None | Placebo | Reimbursement; SMR important; stage IIB-IIC added 2022 |
| Italy | AIFA | 2020 → 2023 | ~1.5 yr | None | Placebo | Class H; managed entry; +regional formulary lag |
| Spain | SEFH / MoH | 2020 → 2023 | ~2 yr | None | Placebo | Financed adjuvant; +17-region formulary lag |
| Japan | PMDA / NHI | 2019 → 2022 | ~0.6 yr | None | Placebo | NHI-listed; small melanoma pool; biennial price cuts |
| China | NMPA | 2021-2022 | ~2 yr | None | Placebo | Approved adjuvant; small pool; modest access |
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.