Registered forecast
75% registered probability event by 2027-07-31 Unresolved
NCCN lists sunvozertinib as a first-line option in EGFR exon 20 insertion NSCLC
FF-001 Registered - Registered probability
- 75%
- Decision by
- 2027-07-31
- Reading window
- 2026-08-01 → 2027-07-31
- Decision stage
- 5 Guideline
- 6 Regulatory
- 7 Coverage
- Baselines it has to beat
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- Authority base rate 62%
- Calendar cycle 40%
- Analyst proxy 80%
nextconsensus.com/forecast/ff-001/ registry snapshot 2026-11-04 Share image
NextConsensus registered this probability on 2026-08-17. It is one of 58 registered forecasts.
The proposition
What was registered
A version of the NCCN Clinical Practice Guidelines in Oncology for Non-Small Cell Lung Cancer carrying a version date on or before 2027-07-31 lists sunvozertinib (ZEGFROVY) as a first-line / initial systemic therapy option, at any NCCN category, for EGFR exon 20 insertion mutation-positive metastatic non-squamous NSCLC.
- Who decides
- National Comprehensive Cancer Network (NCCN), NSCLC Guidelines Panel (US)
- Decision stageThe kind of body that has to act: a guideline panel, a regulator, or a payer. The ladder, rung by rung
- Rung 5: Guideline action — Formal recommendation change by a recognized guideline body: grade shift, new/retracted endorsement, population expansion/restriction.
- Decision typeThe type of decision this forecast is counted with, such as FDA actions by their goal dates
- NCCN guideline reclassification
- Scope
- EGFR exon 20 insertion mutation-positive metastatic non-squamous NSCLC
The estimate
The number and the baselines it has to beat
The estimate that the named body takes the action by the deadline, from what was public at the cutoff.
The alternatives it was registered against, each with the reasoning that produced it. They were set at registration: how often this kind of decision happens on time, what the calendar alone suggests, and a reading of the same public record without this method. Each one's reasoning shows whether it is a count of past decisions or an estimate.
Reference class: agents with a positive randomized phase 3 in a molecularly defined NSCLC subset appearing in an NCCN NSCLC line-of-therapy recommendation within 12 months of publication. Recent precedent in this guideline (alectinib adjuvant post-ALINA, amivantamab first-line post-PAPILLON, sevabertinib in ERBB2) is consistently fast. Estimate from precedent, not an enumerated count — the enumerated corpus is the object of the external-transition-forecast-v1 study and does not yet exist. Recorded as the honest state of this baseline at the cutoff.
A model that knows only NCCN's revision cadence. The NSCLC guideline is revised several times a year, so the probability that at least one revision opportunity falls inside a 12-month window is approximately 1.0. Having no evidence input, such a model cannot discriminate between pending candidates and defaults to the unconditional per-candidate incorporation rate, which is well below the phase-3-conditioned rate above. The output is the product of opportunity and that unconditional rate, recorded as the model's value at the cutoff.
A thoracic-oncology analyst reading the same public record on 2026-07-31 — NEJM-published positive phase 3, Breakthrough Therapy Designation, first-line sNDA submitted, a $600m upfront global license — would call listing highly likely and treat FDA review timing as the only serious question. Estimated by reconstructing that read, not by surveying analysts.
Guideline listing (NCCN, ESMO): offered on judgment, with no calibration figure until 15 in the class have resolved.
The method and every record are public, so you can check the work.
Comparator: Rung 6: Regulatory action (FDA sNDA approval). Date the FDA approves the first-line supplemental NDA, or a publicly announced decision that ends that pathway.
The clock
Dates that constrain the record
- Evidence as of
- 2026-07-31
Nothing after this date informed the estimate. - Registered
- 2026-08-17
Frozen and hashed. - Reading window
- 2026-08-01 → 2027-07-31
When the outcome can be read against the rule. - Event by
- 2027-07-31
The final qualifying action date; the frozen resolution rule defines what counts. Add to calendar
ad43205978351a4affaeb1d6b2cbe00dd6aa0bdf3ac78fd24f9d7259ca3f34fd · operator record jc-1786944950479-571589a7 Around this record
- Sunvozertinib · first-line NSCLC
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- FF-003 · Sunvozertinib · first-line approval by March event by 2027-03-31
- FF-002 · Sunvozertinib · first-line approval event by 2027-07-31
- FF-004 · Sunvozertinib · FDA approval before NCCN listing event by 2027-07-31
- This kind of deadline
- The evidence
- Check it, follow it
Single-claim evaluation
Evaluating a claim that NCCN could change?
Name the claim, who decides it, and the date your team commits to: a P&T meeting, an HTA submission, a label negotiation, a deal closing. The stake need not be ownership — a claim you evaluate, finance, advise on, or rely upon is enough. Yours is registered under the same rules as the forecast on this page.
Resolution
The rule that settles the forecast
Resolves YES if any NCCN NSCLC guideline version dated on or before 2027-07-31 names sunvozertinib (or ZEGFROVY) anywhere in the initial-systemic-therapy recommendation set for EGFR exon 20 insertion mutation-positive metastatic non-squamous NSCLC, at any category (1, 2A, 2B, or 3) and whether or not it is marked preferred. The adjudicator reads the NSCLC algorithm page for initial systemic therapy in EGFR exon 20 insertion mutation-positive disease and the corresponding systemic therapy tables, in the latest version dated on or before 2027-07-31. Resolves NO if no such version names it there. Listing confined to subsequent-line or post-progression therapy does NOT count. Access requires free NCCN registration; no clinical judgement about the drug is needed to apply this rule.
Source the rule names: NCCN NSCLC guideline — initial systemic therapy algorithm and tables for EGFR exon 20 insertion mutation-positive disease, latest version dated on or before 2027-07-31
Readers: Resolver A, clinical methodology; Resolver B, payer evidence. The same two reader roles are assigned to every forecast registered so far.
What this record will show once it resolves
Beside every result, the count for its class (NCCN guideline reclassification): registered, resolved, unresolved, and expired. One forecast is one instance, not a rate.
- The finding
- As the rule above reads it: occurred on time, did not occur, or left unscored.
- The readers and their sources
- Two reader roles read the source named above: Resolver A, clinical methodology; Resolver B, payer evidence. Who adjudicated it is named here, with the sources they read when the adjudication lists them. Being named as a reader means applying the frozen rule to the public record; it is not support for the estimate, the method, or NextConsensus.
- The number against its baselines
- 75% beside three baselines, each scored by the same rule (squared error), so a reader can see how the record did against each of them.
Reasoning
Why this number, and what would break it
Mechanism
Hypothesis, not access — NCCN panel deliberation is closed. Primary path: the US supplemental NDA for the first-line indication, submitted on or before 2026-07-14 and carrying FDA Breakthrough Therapy Designation in this setting, is granted priority review and approved inside the window; NCCN then incorporates the new indication at its normal post-approval cadence, which for this guideline has historically been one to two versions. Secondary path: the panel lists the agent ahead of FDA action on the strength of the NEJM-published randomized phase 3, which it does occasionally for breakthrough-designated agents in molecularly defined subsets. The two paths are not independent — both are driven by the same evidence event — which is why the forecast sits below the ceiling implied by the regulatory path alone.
Against
The WU-KONG28 control arm was platinum doublet alone, not the category-1 preferred regimen the guideline already lists; the guideline requires registration and version dates were unconfirmed at cutoff
When the proposition would be ill-posed
The proposition would be ill-posed if: NCCN restructures the EGFR exon 20 insertion pages such that 'initial systemic therapy' is no longer a distinguishable recommendation set; NCCN withdraws public version-dated distribution of the NSCLC guideline; or the agent is withdrawn from the US market, in which case no listing can occur and the proposition resolves NO on its plain terms rather than being voided. A brand-name change following the AstraZeneca license does not void it — the rule matches on the INN 'sunvozertinib' as well as the brand. Listing restricted to a narrower first-line population than the full exon20ins group still counts as YES, provided it is a first-line recommendation.
Frozen covariatesThe facts about the evidence and the authority's process that were frozen with the forecast at its cutoff
The state of the record at the cutoff
Recorded as they stood on 2026-07-31, including the 3 fields whose values were unknown then. Those are left unknown rather than filled in.
- review pathway
- FDA Breakthrough Therapy Designation granted for the first-line setting (per AstraZeneca release, 2026-07-14); the forecast object itself is an NCCN panel revision, which follows NCCN's continuous-update process rather than a statutory clock
- submission type
- supplemental New Drug Application — efficacy supplement for a new line of therapy in an already-approved molecule
- evidence class
- randomized, open-label, multinational phase 3 (WU-KONG28), published in the New England Journal of Medicine 2026-05-29 and presented as an ASCO late-breaking abstract
- pivotal n
- 324 randomized 1:1
- endpoint type
- progression-free survival by blinded independent central review (primary; 10.3 vs 7.5 months per BICR, HR 0.65, p=0.0008); overall survival not reported as mature at the 2026-01-16 data cutoff
- approved competitors in class
- 1 — amivantamab plus carboplatin/pemetrexed, FDA-approved first-line for EGFR exon20ins on PAPILLON, and widely reported as the NCCN category 1 preferred first-line option for this subset. The category claim is from secondary reporting, NOT from a primary source archived here: the guideline requires registration and was not retrievable for archiving at the cutoff. Load-bearing either way — the WU-KONG28 control arm was platinum doublet alone rather than this regimen, so the trial does not establish superiority over the standard the guideline already recommends, which is the main argument for a lower category or a slower listing.
- months since last guideline revision
- unknown — NCCN NSCLC version dates could not be confirmed against a primary source at the cutoff; the guideline itself requires registration and public secondary reporting of 2026 version dates was mutually inconsistent
- panel cycle position
- unknown — see months_since_last_guideline_revision. The NSCLC guideline is revised several times per year, so procedural opportunity within the window is effectively certain; where the window falls in the cycle is not known.
- sponsor request status
- unknown — NCCN does not publish manufacturer submission requests
- odac referral
- none announced as of the availability cutoff
- sponsor state change
- AstraZeneca took an exclusive global license from Dizal on 2026-07-14, with $600m upfront and up to $900m in milestones — a change in the commercial capacity behind guideline and reimbursement engagement, occurring 17 days before this cutoff
Sources
Everything the estimate was built from
Each was retrieved on or before the 2026-07-31 cutoff and archived at the digest shown. If a publisher edits a page after the fact, the digest stops matching and the substitution is visible.
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SRC-001Dizal press release announcing WU-KONG28 phase 3 results (2026-05-29): PFS 10.3 vs 7.5 months per the release; HR 0.65, p=0.0008; confirms prior US and China accelerated approvals in relapsed/refractory disease -
SRC-002PubMed record for the NEJM primary publication (PMID 42212913, doi 10.1056/NEJMoa2604461, 2026-05-29), 'First-Line Sunvozertinib in NSCLC with EGFR Exon 20 Insertion Mutations'. Archived via PubMed rather than the publisher: nejm.org served a bot-challenge page, not the article. -
SRC-003AstraZeneca press release (2026-07-14) announcing the exclusive global license from Dizal. Load-bearing: the only archived primary source confirming the first-line supplemental NDA to the US FDA and FDA Breakthrough Therapy Designation in this setting. Both facts drive the probability. -
SRC-004Dizal press release: China NMPA accepted the first-line NDA with Priority Review -
SRC-005ASCO Post coverage of the WU-KONG28 first-line results (June 2026) — independent secondary reporting of the same readout -
SRC-006PubMed record for the Cancer Discovery commentary 'Rare EGFRm NSCLC: More First-Line Options Emerge' (PMID 42224429, 2026-07-01) — contemporaneous field read of the first-line landscape in this subset