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.
NCT04624204; dual primary PFS+OS; AstraZeneca/Lynparza.
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. KEYLYNK-013 tests adding pembrolizumab (concurrent with chemoradiation, then consolidation), with or without olaparib, in newly diagnosed limited-stage SCLC. It follows the ADRIATIC precedent (durvalumab consolidation improved OS/PFS in LS-SCLC), but its own OS/PFS endpoints have not read out, and the olaparib arm shares the elevated risk seen across the KEYLYNK program.
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 Merck's PD-1 franchise; Lynparza (olaparib) partnered with AstraZeneca 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.
Limited-stage small-cell lung cancer is treated with concurrent chemoradiotherapy; the ADRIATIC trial recently established consolidation durvalumab as a new standard by improving OS and PFS. KEYLYNK-013 (MK-7339-013) tests whether pembrolizumab given concurrently with CRT and then as consolidation, with or without the PARP inhibitor olaparib, improves outcomes in newly diagnosed LS-SCLC, versus CRT alone.
An attempt to plant pembrolizumab in the LS-SCLC consolidation setting, where AstraZeneca's durvalumab (ADRIATIC) has moved first. SCLC's high genomic instability offers a rationale for adding a PARP inhibitor, but the olaparib add-on inherits the credibility problem from the NSCLC KEYLYNK failures. The strategically important comparison is whether pembrolizumab can match/beat the emerging durvalumab standard; the olaparib arm is a higher-risk deepening bet.
Randomised, placebo-controlled, double-blind Phase 3 (MK-7339-013). Newly diagnosed LS-SCLC randomised 1:1:1 to (A) pembrolizumab + CRT then pembrolizumab + olaparib placebo; (B) pembrolizumab + CRT then pembrolizumab + olaparib; (C) placebo + CRT then placebo. Primary endpoints OS and PFS.
| Agent / regimen | Mechanism | Trial | Status |
|---|---|---|---|
| Consolidation durvalumab (ADRIATIC)AstraZeneca | anti-PD-L1 consolidation after CRT | ADRIATIC | Live threatPositive Phase 3 (OS/PFS) establishing durvalumab consolidation as new LS-SCLC standard, the benchmark. |
| Concurrent CRT aloneStandard of care | chemoradiotherapy | Historical SOC | Pool erosionThe placebo/control arm, prior LS-SCLC standard before IO consolidation. |
| Olaparib (Lynparza) armMerck / AstraZeneca | PARP inhibitor + anti-PD-1 | KEYLYNK program | Own pipelineHigher-risk add-on given PARP+PD-1 failures in NSCLC. |
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.