{"documentId":"1M2KOLAdvBoardApr2026_klm765NoPqRsTuVwXyZ12AbC","title":"KOL Advisory Board — Apr 2026 Synthesis","revisionId":"rev-1M2KOLAdvBoa","body":{"content":[{"sectionBreak":{"sectionStyle":{"columnSeparatorStyle":"NONE","contentDirection":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":60,"textRun":{"content":"Zenvara/Veltarix KOL Advisory Board — April 2026 Synthesis\n","textStyle":{"bold":true}}}],"paragraphStyle":{"namedStyleType":"TITLE","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":200,"textRun":{"content":"Convened: April 18-19, 2026, Madrid. Format: closed-door, two-day, in-person. Chair: Karen Wu, MSL Lead. Distribution: Medical Affairs leadership, VP Commercial, HEOR Director, Clinical Development.\n","textStyle":{}}}],"paragraphStyle":{"namedStyleType":"NORMAL_TEXT","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":10,"textRun":{"content":"Overview\n","textStyle":{"bold":true}}}],"paragraphStyle":{"namedStyleType":"HEADING_2","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":590,"textRun":{"content":"The April 2026 KOL Advisory Board convened eight oncology key opinion leaders across the United States and Europe to discuss the Zenvara/Veltarix clinical evidence base, the emerging real-world experience at 6-12 months post-launch, and the strategic implications for our 2L program (ZENITH-2) and indication expansion. The session was structured in three half-days: clinical evidence and gaps (Day 1 morning), real-world experience and HCP unmet needs (Day 1 afternoon), and future-state strategic positioning (Day 2). Eight KOLs attended; one (Dr. Spigel, Sarah Cannon) joined remotely.\n","textStyle":{}}}],"paragraphStyle":{"namedStyleType":"NORMAL_TEXT","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":11,"textRun":{"content":"Attendees\n","textStyle":{"bold":true}}}],"paragraphStyle":{"namedStyleType":"HEADING_2","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":87,"textRun":{"content":"Dr. James Mok (Chinese University of Hong Kong) — Asia-Pacific KOL, ZENITH-1 site PI.\n","textStyle":{}}}],"paragraphStyle":{"namedStyleType":"NORMAL_TEXT","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":91,"textRun":{"content":"Dr. Solange Peters (Lausanne University Hospital) — Europe regional KOL, IASLC President.\n","textStyle":{}}}],"paragraphStyle":{"namedStyleType":"NORMAL_TEXT","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":74,"textRun":{"content":"Dr. Peter Schmid (Barts Cancer Institute, London) — Europe regional KOL.\n","textStyle":{}}}],"paragraphStyle":{"namedStyleType":"NORMAL_TEXT","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":82,"textRun":{"content":"Dr. Caroline Robert (Gustave Roussy, Paris) — France regional KOL, ASCO faculty.\n","textStyle":{}}}],"paragraphStyle":{"namedStyleType":"NORMAL_TEXT","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":55,"textRun":{"content":"Dr. Naiyer Rizvi (Memorial Sloan Kettering) — US KOL.\n","textStyle":{}}}],"paragraphStyle":{"namedStyleType":"NORMAL_TEXT","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":67,"textRun":{"content":"Dr. Suresh Ramalingam (Winship Cancer Institute, Emory) — US KOL.\n","textStyle":{}}}],"paragraphStyle":{"namedStyleType":"NORMAL_TEXT","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":113,"textRun":{"content":"Dr. Anand Mehta (Memorial Sloan Kettering) — US KOL, primary Zenvara prescriber, MSL relationship via Karen Wu.\n","textStyle":{}}}],"paragraphStyle":{"namedStyleType":"NORMAL_TEXT","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":91,"textRun":{"content":"Dr. David Spigel (Sarah Cannon Research Institute) — US KOL (joined remotely Day 1 only).\n","textStyle":{}}}],"paragraphStyle":{"namedStyleType":"NORMAL_TEXT","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":35,"textRun":{"content":"Day 1 morning — Clinical evidence\n","textStyle":{"bold":true}}}],"paragraphStyle":{"namedStyleType":"HEADING_2","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":420,"textRun":{"content":"Dr. Mok opened with a review of ZENITH-1 long-term follow-up data. Consensus that the 4-year OS data is convincing for the indicated population. Question raised by Dr. Peters: does the trial's PD-L1 testing cutoff (TPS ≥ 50%) miss patients who would benefit from intermediate expression (1-49%)? Active discussion; consensus that the IMpact-2 trial readout in late 2026 will be the data point that decides positioning.\n","textStyle":{}}}],"paragraphStyle":{"namedStyleType":"NORMAL_TEXT","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":433,"textRun":{"content":"Dr. Schmid raised the question of subgroup analysis by PD-L1 expression more granularly (50-79% vs 80%+). Karen confirmed our subgroup analysis is complete and will be included in the NICE submission (asset CL-004). Dr. Schmid: 'This is the critical analysis. If TPS 50-79% benefit is materially smaller than TPS 80%+, the EAG will likely restrict positioning.' Action: ensure Module B includes the subgroup with full transparency.\n","textStyle":{}}}],"paragraphStyle":{"namedStyleType":"NORMAL_TEXT","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":275,"textRun":{"content":"Dr. Mehta emphasized real-world durability as the unresolved question: 'What is the 5-year OS in practice, in patients not selected for trial enrollment? That number is what matters to me at the bedside.' Action: prioritize ZEN-RWD interim analysis publication for Q3 2026.\n","textStyle":{}}}],"paragraphStyle":{"namedStyleType":"NORMAL_TEXT","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":288,"textRun":{"content":"Dr. Ramalingam asked about the safety profile in patients with mild renal impairment (eGFR 60-89). ZENITH-1 enrolled patients with eGFR ≥ 50 mL/min; the 50-60 subgroup is small (n=42). Consensus that real-world safety in this subgroup is important; data extraction from ZEN-RWD planned.\n","textStyle":{}}}],"paragraphStyle":{"namedStyleType":"NORMAL_TEXT","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":41,"textRun":{"content":"Day 1 afternoon — Real-world experience\n","textStyle":{"bold":true}}}],"paragraphStyle":{"namedStyleType":"HEADING_2","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":414,"textRun":{"content":"Dr. Mehta described his MSK practice experience with Zenvara through April 2026. Approximately 28 patients started on Zenvara, 22 still on therapy at the time of the meeting. Median duration 6.4 months in his practice (vs trial 11.4 months at the same time-on-treatment milestone). His attribution: prior-authorization delays at UHC commercial book of patients are creating early attrition before therapy starts.\n","textStyle":{}}}],"paragraphStyle":{"namedStyleType":"NORMAL_TEXT","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":346,"textRun":{"content":"Dr. Rizvi shared similar pattern at MSK: 'The patients who can't start because PA takes too long are not in the denominator we should be looking at; they're prescribed Zenvara, but they don't get it.' Karen made note to flag to the market access team — this is the same signal Aisha and Marco have been triangulating through the launch tracker.\n","textStyle":{}}}],"paragraphStyle":{"namedStyleType":"NORMAL_TEXT","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":232,"textRun":{"content":"Dr. Peters described European experience (still pre-launch in most of Europe). Italian and Spanish access pilots are encouraging — patient access programs are working well in those markets. UK access pending NICE decision Q4 2026.\n","textStyle":{}}}],"paragraphStyle":{"namedStyleType":"NORMAL_TEXT","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":219,"textRun":{"content":"Dr. Robert raised the question of patient-reported outcomes data. ZENITH-1 collected EQ-5D-5L and EORTC QLQ-C30 plus QLQ-LC13. Sara confirmed the PRO data is being prepared for submission and for separate publication.\n","textStyle":{}}}],"paragraphStyle":{"namedStyleType":"NORMAL_TEXT","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":316,"textRun":{"content":"Dr. Schmid: 'The other unmet need is the post-progression sequencing question. After Zenvara progression in 1L, what do we offer? The ZENITH-2 program will answer the re-treatment question, but we also need data on chemo-IO combinations as 2L.' Active discussion; Karen took note for the clinical development team.\n","textStyle":{}}}],"paragraphStyle":{"namedStyleType":"NORMAL_TEXT","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":31,"textRun":{"content":"Day 2 — Strategic positioning\n","textStyle":{"bold":true}}}],"paragraphStyle":{"namedStyleType":"HEADING_2","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":260,"textRun":{"content":"Dr. Mok: 'The competitive landscape in 1L NSCLC PD-L1 high is essentially Zenvara, pembrolizumab, and atezolizumab. Differentiation is on long-term durability and tolerability. The Q6W dosing is a real practice differentiator that should be emphasized more.'\n","textStyle":{}}}],"paragraphStyle":{"namedStyleType":"NORMAL_TEXT","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":213,"textRun":{"content":"Dr. Peters: 'For European HTA, the head-to-head versus pembrolizumab in ZENITH-1 is the critical data point. Without that, NICE and G-BA would have positioned Zenvara as me-too. The H2H is the entire HTA story.'\n","textStyle":{}}}],"paragraphStyle":{"namedStyleType":"NORMAL_TEXT","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":311,"textRun":{"content":"Dr. Schmid: 'Looking forward — if you can layer ZENITH-2 (2L re-treatment) positive on top of ZENITH-1 (1L positive), you have the franchise. If ZENITH-2 fails, you have a 1L-only product and a different commercial picture.' This was the most explicit articulation of the strategic tension during the meeting.\n","textStyle":{}}}],"paragraphStyle":{"namedStyleType":"NORMAL_TEXT","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":163,"textRun":{"content":"Dr. Mehta: 'The KOL community is split on whether re-treatment with the same agent post-progression makes biological sense. The data will need to be very clean.'\n","textStyle":{}}}],"paragraphStyle":{"namedStyleType":"NORMAL_TEXT","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":252,"textRun":{"content":"Dr. Robert: 'Adjuvant breast cancer indication — what is the timeline?' Karen responded: Phase 3 design pending FDA Type B meeting Q3 2026. Dr. Robert: 'If you can get this to data within 4-5 years, it is the most consequential indication expansion.'\n","textStyle":{}}}],"paragraphStyle":{"namedStyleType":"NORMAL_TEXT","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":277,"textRun":{"content":"Dr. Ramalingam closed the meeting with: 'The biggest unmet need in NSCLC right now is the patient who has good initial response to immunotherapy and then progresses. That patient does not have a clear next-line standard. If ZENITH-2 succeeds, you will own that conversation.'\n","textStyle":{}}}],"paragraphStyle":{"namedStyleType":"NORMAL_TEXT","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":22,"textRun":{"content":"Themes and synthesis\n","textStyle":{"bold":true}}}],"paragraphStyle":{"namedStyleType":"HEADING_2","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":172,"textRun":{"content":"Theme 1 — Real-world durability is the unresolved evidence question (raised by Mehta, Schmid, Rizvi). Action: prioritize ZEN-RWD interim analysis publication for Q3 2026.\n","textStyle":{}}}],"paragraphStyle":{"namedStyleType":"NORMAL_TEXT","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":181,"textRun":{"content":"Theme 2 — PA-related access friction is materially affecting real-world experience (raised by Mehta, Rizvi). Action: surface to market access team — same signal Aisha is tracking.\n","textStyle":{}}}],"paragraphStyle":{"namedStyleType":"NORMAL_TEXT","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":149,"textRun":{"content":"Theme 3 — Subgroup analysis by PD-L1 expression cutoff is critical for European HTA (raised by Schmid, Peters). Action: confirmed in NICE Module B.\n","textStyle":{}}}],"paragraphStyle":{"namedStyleType":"NORMAL_TEXT","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":155,"textRun":{"content":"Theme 4 — Q6W dosing under-emphasized in commercial messaging (raised by Mok). Action: review with commercial and the Field Force Activity Playbook v3.x.\n","textStyle":{}}}],"paragraphStyle":{"namedStyleType":"NORMAL_TEXT","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":203,"textRun":{"content":"Theme 5 — ZENITH-2 (2L re-treatment) is the strategic pivot for the franchise (raised by Schmid, Mehta, Ramalingam). Action: clinical development team to brief separately at the May 22 internal review.\n","textStyle":{}}}],"paragraphStyle":{"namedStyleType":"NORMAL_TEXT","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":10,"textRun":{"content":"Quotable\n","textStyle":{"bold":true}}}],"paragraphStyle":{"namedStyleType":"HEADING_2","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":76,"textRun":{"content":"'The 4-year OS data is convincing in the indicated population.' — Dr. Mok.\n","textStyle":{}}}],"paragraphStyle":{"namedStyleType":"NORMAL_TEXT","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":98,"textRun":{"content":"'For European HTA, the head-to-head versus pembrolizumab is the entire HTA story.' — Dr. Peters.\n","textStyle":{}}}],"paragraphStyle":{"namedStyleType":"NORMAL_TEXT","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":55,"textRun":{"content":"'Real-world durability is the question.' — Dr. Mehta.\n","textStyle":{}}}],"paragraphStyle":{"namedStyleType":"NORMAL_TEXT","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":196,"textRun":{"content":"'The patient who has good initial response to immunotherapy and then progresses does not have a clear next-line standard. If ZENITH-2 succeeds, you will own that conversation.' — Dr. Ramalingam.\n","textStyle":{}}}],"paragraphStyle":{"namedStyleType":"NORMAL_TEXT","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":12,"textRun":{"content":"Next steps\n","textStyle":{"bold":true}}}],"paragraphStyle":{"namedStyleType":"HEADING_2","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":102,"textRun":{"content":"1. ZEN-RWD interim analysis prioritized for Q3 2026 publication. Owner: Clinical Development + HEOR.\n","textStyle":{}}}],"paragraphStyle":{"namedStyleType":"NORMAL_TEXT","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":121,"textRun":{"content":"2. Internal brief on PA-related access friction in major academic centers — Marco + Aisha to align messaging by May 18.\n","textStyle":{}}}],"paragraphStyle":{"namedStyleType":"NORMAL_TEXT","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":71,"textRun":{"content":"3. PD-L1 subgroup analysis confirmed in NICE Module B (asset CL-004).\n","textStyle":{}}}],"paragraphStyle":{"namedStyleType":"NORMAL_TEXT","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":112,"textRun":{"content":"4. Commercial messaging review to surface Q6W dosing advantage more prominently. Owner: Marketing + Sales Ops.\n","textStyle":{}}}],"paragraphStyle":{"namedStyleType":"NORMAL_TEXT","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":90,"textRun":{"content":"5. ZENITH-2 program review for the May 22 internal session. Owner: Clinical Development.\n","textStyle":{}}}],"paragraphStyle":{"namedStyleType":"NORMAL_TEXT","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":83,"textRun":{"content":"6. Next KOL Advisory Board: October 2026 (post-ASCO and post-ESMO), location TBD.\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":160,"textRun":{"content":"ASCO 2026 Readout (1L9…), Competitor Monitoring Tracker (1N5…), Evidence Dossier Index (1I8…). ZENITH-2 program brief held separately by Clinical Development.\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"}