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.
NCT04210115; dual primary OS+EFS. READ OUT AND FAILED: Merck's Q1 2026 results (30 Apr 2026) state pembrolizumab + dCRT 'did not show a statistically significant improvement in the primary endpoint of EFS'. No HR or median disclosed; OS, the second dual primary, is unreported in any public source. No results publication exists (Europe PMC returns only the 2021 design paper, PMID 33533655). Status stays phase3 because Merck has not declared the programme stopped - but this must not read as pending.
Baseline profile - No forecast model has been built for this indication yet. What is shown is the approval and trial record, with its sources.
milestone crossed (confirmed quarter)·upcoming / estimated (~)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). Pipeline: quarters projected from readout timing, not yet approved. Cross-checked against Merck & Co. disclosures and regulator databases.
Synthesised from this indication's verified milestones (pivotal readout, regulatory approvals/decisions) and the asset's expected LOE: filled = passed, open = upcoming. Competitor-level catalysts are tracked on the disease-landscape view below.
No efficacy reported yet. KEYNOTE-975 tests adding pembrolizumab to definitive chemoradiotherapy in locally advanced, surgery-ineligible esophageal carcinoma (squamous or adenocarcinoma/Siewert type 1). It extends the KEYNOTE-590-validated pembrolizumab role from metastatic into definitive-CRT disease, but the OS / event-free survival endpoints have not read out, outcome unknown. Note: in the analogous gastroesophageal CRT setting, the competing KEYNOTE-585 perioperative program had mixed results, a cautionary signal.
Development to approval
This indication is not yet approved; approval is expected, not granted. Per-market timing is modelled from the Phase 3 readout plus standard regulatory lags (US/EU ~1 yr; Japan/China ~2 yr), an estimate, not company guidance.
Intramural program. Operates within the KEYNOTE-590 (pembrolizumab + chemo, 1L advanced/metastatic esophageal, approved) patient pool, which is already monetised on its own page. Any approval here would re-segment that pool, not add a new one, so it carries no standalone revenue line to avoid double-counting the franchise.
For locally advanced esophageal carcinoma not amenable to curative surgery, definitive concurrent chemoradiotherapy (CRT) is standard. Pembrolizumab is already established in advanced/metastatic esophageal cancer via KEYNOTE-590 (pembro + chemo). KEYNOTE-975 (MK-3475-975) tests whether adding pembrolizumab to definitive CRT improves OS and event-free survival, with prespecified analysis in CPS ≥10, squamous, and all-comer cohorts.
Moves pembrolizumab earlier, from metastatic esophageal disease into the definitive-CRT (potentially curative-intent) setting, enlarging the treated pool and deepening the franchise's hold across esophageal cancer stages. Success would define a new IO+CRT standard in a setting currently served by chemoradiation alone. Because it addresses surgery-ineligible localised disease, the pool is largely additive rather than overlapping with the metastatic KEYNOTE-590 indication.
Double-blind, placebo-controlled, randomised (1:1) Phase 3 (MK-3475-975). Patients ≥18 with locally advanced esophageal SCC or adenocarcinoma / Siewert type 1, ineligible for curative surgery, no prior chemo/radiation. Pembrolizumab 200 mg Q3W ×8 then 400 mg Q6W ×5 (or placebo) added to definitive CRT. Primary endpoints OS and event-free survival in CPS ≥10, squamous, and ITT cohorts.
| Agent / regimen | Mechanism | Trial | Status |
|---|---|---|---|
| Definitive chemoradiotherapy aloneStandard of care | concurrent chemoradiation | Historical SOC | Pool erosionThe placebo comparator, current standard in surgery-ineligible localised esophageal cancer. |
| Pembrolizumab + chemo (KEYNOTE-590)Merck | anti-PD-1 + chemo | KEYNOTE-590 | Own pipelineMerck's own approved esophageal indication (metastatic), adjacent pool. |
| Nivolumab-based regimens (CheckMate-577/648)Bristol Myers Squibb | anti-PD-1 (± ipilimumab / chemo) | CheckMate-577 / -648 | Live threatCompeting IO standards in adjuvant and advanced esophageal cancer. |
No commercial forecast. This is an early Phase 2 program with no efficacy read-out yet, so a per-country revenue model would be speculation, not analysis. We publish a forecast once a registrational read-out de-risks the setting. The figures on the approved- and Phase 3indication pages already capture this asset's monetised and near-term pools.
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.