{"documentId":"1L9ASCO2026Readout_hij098KlMnOpQrStUvWxYz12345","title":"ASCO 2026 Readout — Competitive Implications for Zenvara","revisionId":"rev-1L9ASCO2026R","body":{"content":[{"sectionBreak":{"sectionStyle":{"columnSeparatorStyle":"NONE","contentDirection":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":58,"textRun":{"content":"ASCO 2026 Readout — Competitive Implications for Zenvara\n","textStyle":{"bold":true}}}],"paragraphStyle":{"namedStyleType":"TITLE","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":203,"textRun":{"content":"Prepared by Jordan Patel, CI Analyst. Distribution: VP Commercial, CCO, Medical Affairs Director, Launch Lead, HEOR Director, regional sales directors. Delivered Thursday May 14 EOD per Dana's request.\n","textStyle":{}}}],"paragraphStyle":{"namedStyleType":"NORMAL_TEXT","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":10,"textRun":{"content":"Headline\n","textStyle":{"bold":true}}}],"paragraphStyle":{"namedStyleType":"HEADING_2","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":491,"textRun":{"content":"The most material development from the ASCO 2026 program affecting Zenvara is the BMS CheckMate-X Phase 3 readout in 2L NSCLC, which missed its primary progression-free survival endpoint. Reported HR 0.91 (95% CI 0.78-1.06), p=0.18. This result reduces the near-term 2L competitive threat from BMS materially; the HR confidence interval overlaps our last cut from ZENITH-2 (the 2L study, ongoing) of HR 0.71, and the CheckMate result is not a clean win for BMS over our likely positioning.\n","textStyle":{}}}],"paragraphStyle":{"namedStyleType":"NORMAL_TEXT","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":27,"textRun":{"content":"Sequence of events (WK19)\n","textStyle":{"bold":true}}}],"paragraphStyle":{"namedStyleType":"HEADING_2","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":303,"textRun":{"content":"Tuesday May 12 10:00 ET — Jordan flagged on Slack that the CheckMate-X abstract title was visible in the ASCO 2026 supplement table of contents, with Kaplan-Meier reported at 18.2 months for the BMS arm. Our last public cut on the comparator was 17.6 months. The KM milestone was the first data point.\n","textStyle":{}}}],"paragraphStyle":{"namedStyleType":"NORMAL_TEXT","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":283,"textRun":{"content":"Tuesday May 12 14:00 ET — Karen Wu (MSL Lead) reviewed the abstract metadata and noted that the HR confidence interval overlaps the ZENITH-2 confidence interval based on the publicly available abstract title and the embargoed abstract preview. Her read: 'not a clean win for them.'\n","textStyle":{}}}],"paragraphStyle":{"namedStyleType":"NORMAL_TEXT","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":117,"textRun":{"content":"Tuesday May 12 16:00 ET — Dana Park (CCO) requested a one-page CI brief by EOD Thursday for executive distribution.\n","textStyle":{}}}],"paragraphStyle":{"namedStyleType":"NORMAL_TEXT","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":255,"textRun":{"content":"Wednesday May 13 09:00 ET — Internal congress alert noted that 4 abstracts in the Zenvara class lift embargo within 24 hours. Key abstracts: CheckMate-X 2L NSCLC (BMS), KEYNOTE-189 5-year update (Merck), DESTINY-Lung-XX (Daiichi/AZ), IMpower-YY (Roche).\n","textStyle":{}}}],"paragraphStyle":{"namedStyleType":"NORMAL_TEXT","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":206,"textRun":{"content":"Thursday May 14 11:00 ET — Embargo lifted on the CheckMate-X full abstract. Confirmed primary PFS endpoint missed; HR 0.91 (95% CI 0.78-1.06), p=0.18. Secondary OS endpoint also non-significant (HR 0.95).\n","textStyle":{}}}],"paragraphStyle":{"namedStyleType":"NORMAL_TEXT","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":91,"textRun":{"content":"Thursday May 14 14:00 ET — Jordan drafted this brief. Reviewed by Karen Wu and Dana Park.\n","textStyle":{}}}],"paragraphStyle":{"namedStyleType":"NORMAL_TEXT","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":52,"textRun":{"content":"Thursday May 14 18:30 ET — Final brief circulated.\n","textStyle":{}}}],"paragraphStyle":{"namedStyleType":"NORMAL_TEXT","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":27,"textRun":{"content":"CheckMate-X result detail\n","textStyle":{"bold":true}}}],"paragraphStyle":{"namedStyleType":"HEADING_2","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":191,"textRun":{"content":"Trial: Phase 3 randomized, double-blind, BMS competitor (compound: nivolumab + relatlimab combination) vs nivolumab monotherapy in 2L metastatic NSCLC after progression on 1L immunotherapy.\n","textStyle":{}}}],"paragraphStyle":{"namedStyleType":"NORMAL_TEXT","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":78,"textRun":{"content":"Patient population: 600 randomized, balanced across PD-L1 expression strata.\n","textStyle":{}}}],"paragraphStyle":{"namedStyleType":"NORMAL_TEXT","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":184,"textRun":{"content":"Primary endpoint: PFS. Result: HR 0.91 (95% CI 0.78-1.06), p=0.18. Median PFS: 4.8 vs 4.2 months. Did not meet pre-specified statistical significance threshold (one-sided p < 0.025).\n","textStyle":{}}}],"paragraphStyle":{"namedStyleType":"NORMAL_TEXT","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":189,"textRun":{"content":"Secondary endpoints: OS HR 0.95 (95% CI 0.81-1.12), median OS 18.2 vs 17.6 months — not statistically significant. ORR 18% vs 14%. Grade 3+ AE rate 38% vs 32% (higher in combination arm).\n","textStyle":{}}}],"paragraphStyle":{"namedStyleType":"NORMAL_TEXT","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":167,"textRun":{"content":"Conclusion: trial did not demonstrate benefit of relatlimab addition to nivolumab in 2L NSCLC. BMS is unlikely to pursue label expansion in 2L based on this readout.\n","textStyle":{}}}],"paragraphStyle":{"namedStyleType":"NORMAL_TEXT","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":54,"textRun":{"content":"Implications for Zenvara — near-term (next 6 months)\n","textStyle":{"bold":true}}}],"paragraphStyle":{"namedStyleType":"HEADING_2","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":237,"textRun":{"content":"Reduced defensive messaging requirement in 2L space. Our previously prepared talk track on BMS competitive risk can be relaxed; reps can refocus their share-of-voice on the 1L positive ZENITH-1 data without the BMS counter-positioning.\n","textStyle":{}}}],"paragraphStyle":{"namedStyleType":"NORMAL_TEXT","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":250,"textRun":{"content":"Patient-level: HCPs treating 2L NSCLC patients now face a more open competitive landscape with no clear standard for 2L post-IO. This creates a window for ZENITH-2 (our own 2L program, currently enrolling) to position upon readout (target Q3 2026).\n","textStyle":{}}}],"paragraphStyle":{"namedStyleType":"NORMAL_TEXT","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":301,"textRun":{"content":"Pricing: BMS pricing power in 2L NSCLC is reduced. Their commercial pressure to maintain net pricing in the existing IO franchise is now greater. Potential downstream: BMS may aggressively defend pembrolizumab market share in 1L through contracting, which could indirectly affect our 1L positioning.\n","textStyle":{}}}],"paragraphStyle":{"namedStyleType":"NORMAL_TEXT","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":51,"textRun":{"content":"Implications for Zenvara — mid-term (6-18 months)\n","textStyle":{"bold":true}}}],"paragraphStyle":{"namedStyleType":"HEADING_2","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":199,"textRun":{"content":"BMS likely to pivot CheckMate program development to 1L combinations or earlier-line settings. The CheckMate-X failure removes one path; BMS will look for other readouts to anchor the 2L franchise.\n","textStyle":{}}}],"paragraphStyle":{"namedStyleType":"NORMAL_TEXT","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":159,"textRun":{"content":"Competitor monitoring tracker should be updated to reflect this — CheckMate-X moves from \"high probability of approval in 2L\" to \"unlikely to seek 2L label\".\n","textStyle":{}}}],"paragraphStyle":{"namedStyleType":"NORMAL_TEXT","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":131,"textRun":{"content":"MSL outreach unchanged. Karen continues Dr. Mehta (Sloan) engagement with the Optum RWE durability data Sara pulled in early May.\n","textStyle":{}}}],"paragraphStyle":{"namedStyleType":"NORMAL_TEXT","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":82,"textRun":{"content":"Other ASCO 2026 readouts affecting Zenvara (preliminary; embargo not yet lifted)\n","textStyle":{}}}],"paragraphStyle":{"namedStyleType":"NORMAL_TEXT","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":262,"textRun":{"content":"KEYNOTE-189 5-year update (Merck): 5-year OS data on first-line pembrolizumab + chemotherapy in NSCLC. Long-term durability data is expected to be positive. Implication: reinforces pembrolizumab as 1L SoC; modest competitive pressure on Zenvara 1L positioning.\n","textStyle":{}}}],"paragraphStyle":{"namedStyleType":"NORMAL_TEXT","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":165,"textRun":{"content":"DESTINY-Lung-XX (Daiichi Sankyo/AstraZeneca): trastuzumab deruxtecan in HER2-mutant NSCLC. Not in direct competition with Zenvara (different biomarker population).\n","textStyle":{}}}],"paragraphStyle":{"namedStyleType":"NORMAL_TEXT","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":187,"textRun":{"content":"IMpower-YY (Roche): atezolizumab data in 1L NSCLC PD-L1 high. Direct competitor positioning, but trial design differs from ZENITH-1. Karen will brief separately on Tuesday post-embargo.\n","textStyle":{}}}],"paragraphStyle":{"namedStyleType":"NORMAL_TEXT","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":21,"textRun":{"content":"Recommended actions\n","textStyle":{"bold":true}}}],"paragraphStyle":{"namedStyleType":"HEADING_2","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":78,"textRun":{"content":"1. Update competitor monitoring tracker (1N5) to reflect CheckMate-X result.\n","textStyle":{}}}],"paragraphStyle":{"namedStyleType":"NORMAL_TEXT","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":148,"textRun":{"content":"2. Refresh defensive 2L messaging — replace BMS-pressure talk track with the new ZENITH-2 forward-looking story for 1L practice managers and KOLs.\n","textStyle":{}}}],"paragraphStyle":{"namedStyleType":"NORMAL_TEXT","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":95,"textRun":{"content":"3. Brief regional sales directors at Friday tracker call (Marco to schedule by EOD Thursday).\n","textStyle":{}}}],"paragraphStyle":{"namedStyleType":"NORMAL_TEXT","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":117,"textRun":{"content":"4. MSL panel session at the May 28 quarterly MSL convening to coordinate Karen + EU MSLs on consistent positioning.\n","textStyle":{}}}],"paragraphStyle":{"namedStyleType":"NORMAL_TEXT","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":188,"textRun":{"content":"5. CI team to monitor BMS public commentary at ASCO press briefings and during investor calls (BMS Q1 2026 earnings May 22). Looking for any signals on Q3-Q4 2026 program prioritization.\n","textStyle":{}}}],"paragraphStyle":{"namedStyleType":"NORMAL_TEXT","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":18,"textRun":{"content":"Cross-references\n","textStyle":{"bold":true}}}],"paragraphStyle":{"namedStyleType":"HEADING_2","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":232,"textRun":{"content":"Competitor Monitoring Tracker (1N5…), KOL Advisory Board Apr 2026 Synthesis (1M2…), 2026 Congress Calendar (1O8…). ASCO source: /api/congress/abstracts?congress=ASCO2026. Slack thread: #competitive-intel (Jordan 10:00 ET Tuesday).\n","textStyle":{}}}],"paragraphStyle":{"namedStyleType":"NORMAL_TEXT","direction":"LEFT_TO_RIGHT"}}}]},"documentStyle":{"pageNumberStart":1,"marginTop":{"magnitude":72,"unit":"PT"},"marginBottom":{"magnitude":72,"unit":"PT"},"marginLeft":{"magnitude":72,"unit":"PT"},"marginRight":{"magnitude":72,"unit":"PT"},"pageSize":{"height":{"magnitude":792,"unit":"PT"},"width":{"magnitude":612,"unit":"PT"}}},"namedStyles":{"styles":[{"namedStyleType":"NORMAL_TEXT","textStyle":{"fontSize":{"magnitude":11,"unit":"PT"}}},{"namedStyleType":"TITLE","textStyle":{"fontSize":{"magnitude":26,"unit":"PT"},"bold":true}},{"namedStyleType":"HEADING_1","textStyle":{"fontSize":{"magnitude":20,"unit":"PT"},"bold":true}},{"namedStyleType":"HEADING_2","textStyle":{"fontSize":{"magnitude":16,"unit":"PT"},"bold":true}}]},"lists":{},"inlineObjects":{},"headers":{},"footers":{},"footnotes":{},"suggestionsViewMode":"DEFAULT_FOR_CURRENT_ACCESS"}