OptiTROP-Lung06 (NCT06711900) is a phase 3 trial in China testing sacituzumab tirumotecan (sac-TMT), Kelun-Biotech’s TROP2 antibody-drug conjugate (not FDA or EMA approved; investigational in this setting), plus pembrolizumab (KEYTRUDA) in place of pemetrexed-platinum chemotherapy for untreated PD-L1-negative nonsquamous NSCLC. At ESMO 2026 (LBA66) and in NEJM, median PFS was 15.0 vs 5.7 months (HR 0.49); OS is immature.
See the LBA66 Results →At the prespecified interim PFS analysis (data cutoff June 9, 2026; median follow-up 9.7 months), median PFS by blinded independent central review was 15.0 months (95% CI 9.9–not estimable) with sac-TMT plus pembrolizumab vs 5.7 months (5.5–7.4) with pemetrexed-platinum plus pembrolizumab (79 vs 126 PFS events in total): HR 0.49 (95% CI 0.36–0.65). The 12-month PFS rate was 51.1% vs 22.8%. The LBA66 abstract and slides print P < 0.0001 against an updated two-sided efficacy boundary of 0.0160; NEJM prints P < 0.001. Investigator-assessed PFS was consistent: HR 0.52 (0.40–0.69).
PFS 15.0 vs 5.7 mo · HR 0.49OS is a secondary endpoint. At the PFS interim analysis there were 36 deaths (15.7%) with sac-TMT plus pembrolizumab and 55 (24.3%) with chemotherapy plus pembrolizumab; median OS was not reached in either arm. The HR for death was 0.58 (95% CI 0.38–0.88), and the 12-month OS rate was 77.6% vs 66.4% (LBA66 slide, labelled “Descriptive Overall Survival at PFS IA”). The investigators and NEJM describe OS as immature; an OS benefit has not been established.
OS HR 0.58 · immatureBy BICR, ORR was 50.2% (43.6–56.9) vs 47.3% (40.7–54.1) and disease control 90.4% vs 88.5%. Deep responses (CR or PR with ≥50% tumor shrinkage) occurred in 28.8% vs 17.3%. Median duration of response was 13.6 months (9.7–NE) vs 6.8 months (4.2–10.6), HR 0.47 (0.29–0.77), and the 12-month DOR rate was 61.7% vs 27.2% (LBA66 slide).
DOR 13.6 vs 6.8 moThe PFS benefit was described as generally consistent across subgroups, with unstratified, exploratory hazard ratios. Point estimates were closer to 1 in women (HR 0.88, 95% CI 0.51–1.51; 64 vs 63 patients) and never smokers (0.80, 0.50–1.29) than in men (0.39) and current or former smokers (0.36). The effect was similar by TROP2 expression: H-score ≤200, HR 0.49; >200, HR 0.59 (LBA66 slide). These subgroups were not powered for separate conclusions.
LBA66 presentation slides (Caicun Zhou, ESMO 2026)| Event, n (%) | Sac-TMT + pembro (n=229) | Chemo + pembro (n=226) |
|---|---|---|
| Grade ≥3 TEAEs | 109 (47.6) | 137 (60.6) |
| Serious TEAEs | 82 (35.8) | 82 (36.3) |
| TEAEs leading to dose reduction | 11 (4.8) | 45 (19.9) |
| TEAEs leading to discontinuation of any study drug | 13 (5.7) | 32 (14.2) |
| TEAEs leading to death | 5 (2.2) | 14 (6.2) |
| Treatment-related AEs leading to death | 1 (0.4) | 3 (1.3) |
| Stomatitis, any grade / grade ≥3 (AESI) | 117 (51.1) / 5 (2.2) | 19 (8.4) / 0 |
| Ocular surface toxicity, any grade (all grade 1–2) | 31 (13.5) | 6 (2.7) |
| Pneumonitis incl. ILD, any grade / grade ≥3 | 24 (10.5) / 4 (1.7) | 31 (13.7) / 7 (3.1) |
Hematologic toxicity was lower with sac-TMT plus pembrolizumab: grade ≥3 anemia 6.1% vs 20.4% and grade ≥3 platelet count decreased 3.9% vs 14.6% (abstract). Grade ≥3 neutrophil count decreased was 19.7% vs 28.8% in the abstract; the adverse-events-of-special-interest slide, which groups neutropenia and febrile neutropenia with it, prints 20.1% vs 29.6%. Alopecia was more common with sac-TMT (62% vs 14%, any grade). Stomatitis was grade 1 in 21.8%, grade 2 in 27.1% and grade 3 in 2.2% of sac-TMT patients; the most common ocular events were dry eye (8.3%), conjunctivitis (5.7%) and increased tearing (5.2%) (LBA66 slides).
Grade ≥3 TEAEs 47.6% vs 60.6%⚠ Investigational. Sacituzumab tirumotecan is not approved by the FDA or the European Medicines Agency for any indication, and first-line sac-TMT plus pembrolizumab for PD-L1-negative NSCLC is not approved anywhere. In China, the NMPA has approved sac-TMT in four other indications: previously treated triple-negative breast cancer, EGFR-mutant nonsquamous NSCLC after EGFR-TKI (two settings) and pretreated HR+/HER2− breast cancer. A first-line application with pembrolizumab for PD-L1 TPS ≥1% NSCLC (OptiTROP-Lung05) is under NMPA priority review. For OptiTROP-Lung06, Kelun-Biotech said in July it plans to discuss the results with the NMPA’s Center for Drug Evaluation. Kelun-Biotech licensed sac-TMT (MK-2870) to Merck (MSD) for all territories outside Greater China in May 2022. Sac-TMT is a different drug from sacituzumab govitecan (TRODELVY). ✓ The control regimen, pembrolizumab plus pemetrexed and platinum, is an FDA-approved first-line standard. The presenter’s conclusion slide states that the results “support sac-TMT + pembro as a potential new first-line treatment option”; that is not a regulatory decision. All 81 registered sites are in China.
Kelun-Biotech press release, Oct 25, 2026 · Kelun-Biotech topline release, Jul 14, 2026 · ClinicalTrials.gov NCT06711900Create a free account, pick the tumor types you cover, and go beyond the tweet — the intelligence pharma teams use to map influence and prepare for engagement:












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OptiTROP-Lung06:🫁 Sac-TMT + pembrolizumab improved median PFS in PD-L1–negative advanced nonsquamous NSCLC (15.0 vs 5.7 months; HR 0.49), with fewer grade 3 or higher adverse events. OS remains immature; follow-up is key. @OncoAlert #ESMO26 #LungCancer #ESMOcommunity @myESMO https://t.co/nIAg7uYbdI
OptiTROP-Lung06: 1L PD-L1-negative, EGFR/ALK-negative nonsquamous NSCLC. Sac-TMT + pembro vs chemo + pembro (N=455): PFS 15.0 vs 5.7 mo HR 0.49 (95% CI 0.36–0.65) OS encouraging but immature. Median follow-up only 9.7 mo. The major limitation: China-only populations.
#תשובות_לשאלות הסבר מופרט על המשמעות הקלינית של מחקר OptiTROP-Lung06 לבקשת @the_drow אז מה היה לנו עד עכשיו... בסרטן ריאות NSCLC לא-קשקשי עם PD-L1 מתחת ל-1%,ללא מוטציות מטרה ברות טיפול כגון EGFR או ALK, כבר שנים אנחנו תקועים באותו מקום: כימותרפיה + קיטרודה זה עובד, אבל לא חלקית... ה-PFS החציוני בדרך כלל סביב 5–7 חודשים, והחולים משלמים מחיר לא קטן ברעילות המטולוגית. בעיקר בגלל שהגידול לא מבטא מספיק PD-L1 ועד עכשיו לא היה לנו משהו טוב יותר להציע לחולים האילו כאן מחקר נכנס לתמונה OptiTROP-Lung06 במקום להוסיף עוד תרופה לכימותרפיה ה״רגילה״, הם שאלו שאלה אחרת: מה יקרה אם נחליף את אותה בתרופה חדישה ממשפחת ה-ADC? כלומר sacituzumab tirumotecan (TROP2 ADC) + קיטרודה, מול הסטנדרט הרגיל של כימותרפיה + קיטרודה. ובניתוח תוצאות הביניים במעקב של כ-9.7 חודשים, 455 חולים (בסין): PFS: 15 חודשים מול 5.7 חודשים (HR 0.49). זה לא שיפור קטן, זה יותר מכפול. אחוז התגובות היה כמעט זהה (50% מול 47%), אבל משך התגובה היה הרבה יותר ארוך 13.6 חודשים מול 6.8. היו גם יותר תגובות עמוקות. ב-OS עדיין מוקדם, אבל כבר רואים מגמה חיובית (HR 0.58), וב-12 חודשים 77.6% מול 66.4% עדיין חיים. כשהבטיחות/תופעות הלוואי של הטיפול החדש מפתיעו לטובה. פחות Grade ≥3 (47.6% מול 60.6%), ופחות רעילות המטולוגית משמעותית. יש יותר סטומטיטיס, אבל ברוב המקרים זה קל-בינוני. בקיצור לא רק יעיל יותר, אלא גם פחות "כבד" מבחינה המטולוגית מהכימו. אז מה זה אומר מבחינה קלינית? עד עכשיו, בחולים עם PD-L1 <1% לא באמת היה לנו משהו טוב יותר מכימותרפיה פשוטה + אימונתרפיה. מחקר OptiTROP-Lung06 מראה, שאפשר להחליף את הכימותרפיה ב-ADC ולקבל שליטה ארוכה יותר במחלה, עם פרופיל בטיחות סביר יותר מבחינת ספירת דם.
#ESMO26 | OptiTROP-Lung06 @NEJM Sac-TMT + pembrolizumab challenges first-line chemo-IO in PD-L1–negative nonsquamous NSCLC: • mPFS: 15.0 vs 5.7 mo; HR 0.49 • Grade ≥3 AEs: 47.6% vs 60.6% Impressive PFS benefit. OS remains immature—longer follow-up will be key. @OncoAlert @Larvol #esmo26
🚨 Could ADCs replace chemotherapy in first-line NSCLC? Exciting results from Phase III OptiTROP-Lung06 at #ESMO26! Sacituzumab tirumotecan + pembrolizumab vs chemo + pembrolizumab in PD-L1-negative NSCLC: 📊 PFS: 15.0 vs 5.7 months ✅ Grade ≥3 AEs: 47.6% vs 60.6% OS data remain immature, but these results could change first-line treatment! #LungCancer @OncoAlert @weoncologists @OpenMedKate @StephenVLiu @GlopesMd @ManuelDomine
Big PFS gain in PD-L1-negative NSCLC. OptiTROP-Lung06 (LBA66): Randomized phase 3, 455 pts, 1L advanced nonsquamous NSCLC (PD-L1 TPS<1%, EGFR/ALK-negative): sac-TMT + pembro vs platinum/pemetrexed + pembro. mPFS 15.0 vs 5.7 mo (HR 0.49 (0.36–0.65), and OS HR 0.58 (0.38–0.88), still immature, but extremely promising! #ESMO26 #LCSM #OncTwitter https://t.co/ssgUKkif6S @OncoAlert @BalazsHalmosMD @ADesaiMD
🐼 THE GAP IS SO WIDE, EVEN A PANDA FITS! OptiTROP-Lung06 | ESMO 2026 | LBA66 🇨🇳 China-only Phase III | 455 patients First-line PD-L1–negative nonsquamous NSCLC. 📈 PFS: 15.0 vs 5.7 mo | HR 0.49 🎯 12-mo PFS: 51.1% vs 22.8% 🔬 ORR: 50.2% vs 47.3% — similar! ⏳ DoR: 13.6 vs 6.8 mo — twice as long! Similar response rates. Far more durable disease control. ⚠️ OS remains immature (HR 0.58). Longer follow-up and broader validation needed. KM curves adapted for illustration; refer to the original publication for exact trajectories. Zhou F et al. NEJM, 2026. https://t.co/71dlz6CwnZ @myESMO @OncoAlert @larvol #ESMO26 #NSCLC #ADC #MVOnco
OptiTROP-Lung06 #ESMO26: 1L sac-TMT+pembro vs chemo-IO, PD-L1-neg nsq NSCLC ➡️ mPFS 15.0 vs 5.7 mo, HR 0.49 ➡️ ORR 50.2 vs 47.3%, mDOR 13.6 vs 6.8 mo ➡️ OS HR 0.58, immature ➡️ G≥3 TEAEs 47.6 vs 60.6% What must ADCs show to replace platinum? @LungCancerRx @OncoAlert @oncodaily https://t.co/5CoJUw2OIp
💍 THE GREAT PARTNER SWAP! OptiTROP-Lung06 | ESMO 2026 | LBA66 Pembrolizumab stays. Sac-TMT replaces chemotherapy! 🎯 PFS: 15.0 vs 5.7 mo | HR 0.49 📊 ORR: 50.2% vs 47.3% — similar! ⏳ DoR: 13.6 vs 6.8 mo — twice as long! ⚖️ Grade ≥3 AEs: 47.6% vs 60.6% 🔍 OS: HR 0.58 — immature; formal benefit unproven. The story? Similar responses, much longer disease control — with a different toxicity profile. Zhou F et al. NEJM. 2026. DOI: 10.1056/NEJMoa2611280 @myESMO @OncoAlert #ESMO26 #NSCLC #ADC #MVOnco
Another major #ESMO26 paper, published in @NEJM today. In PD-L1-negative advanced nonsquamous lung cancer, sacituzumab tirumotecan (a TROP2-targeted ADC) plus pembrolizumab improved median PFS (time without progression) from 5.7 to 15 months, replacing chemotherapy rather than adding to it. OS is immature, and these China-only results need global confirmation.
OptiTROP-Lung06 🫁 Sac-TMT + pembrolizumab: A substantial PFS benefit in 1L PD-L1-negative advanced NSCLC, with OS data still immature. @OncoAlert #ESMO26 #LungCancer #Lcsm #ESMOAmbassadors #ESMOcommunity @myESMO https://t.co/XTv3FAFHOZ
🔥🚨@OncoAlert Hot off the press. Just published @NEJM in conjunction with presentation @myESMO #ESMO26 results of: ⭐️#OptiTROP-#Lung06 phase 3 trial of: ❇️#Sacituzumab Tirumotecan (Sac-TMT)+ #Pembrolizumab Vs #Chemotherapy + #Pembrolizumab 🎯For #1stLine Tx of #PDL1 #negative (PD-L1 < 1%) advanced #NonSquamous non-small-cell #LungCancer (#NSCLC) WITHOUT genomic alterations. Study showed: ‼️Statistically significant & clinically meaningful ⬆️#ProgressionFreeSurvival Benefit. ✅ #mPFS 15.0 vs 5.7 mo (HR 0.49, p<0.001) ✅#ORR 50.2% and 47.3% ✅Immature #OS data; #HR: 0.49 P<0.001 ✅≥ Grade 3 #AEs: 47.6% vs 60.6% 👇🏻 https://t.co/SbNKX2ZOPm
Context: per the NEJM abstract, the hazard ratio for death was 0.58 (95% CI 0.38–0.88), with OS immature; HR 0.49 (P<0.001) is the PFS result.
🚨 #ESMO26 | OptiTROP-Lung06 (Phase III) Impressive PFS with sacituzumab tirumotecan + pembrolizumab vs chemotherapy + pembrolizumab in PD-L1-negative advanced non-squamous NSCLC: 📈 Median PFS: 15.0 vs 5.7 months 📈 12-month PFS: 51.1% vs 22.8% Could ADC + IO redefine first-line NSCLC treatment? Awaiting mature OS and safety data. #LungCancer #NSCLC
Melissa Johson doing an excellent job discuuing those lung studies and ADC #ESMO2026 https://t.co/3Piy2Re2GH
Could OptiTROP-Lung06 change first-line treatment in PD-L1-negative NSCLC? At #ESMO26, Prof. Caicun Zhou presented striking Phase III results: Sac-TMT + pembrolizumab vs chemo + pembrolizumab: PFS: 15.0 vs 5.7 months (HR 0.49) A potential practice-changing result. @OncoDaily @OncoAlert @myESMO #ESMO2026 #LungCancer #ADC
Johnson: explains the differences in toxicity in the SacTMT trials as likely dose related. Asks if there is a synergy with SacTMT and Pembro? #LCSM #ESMO26 https://t.co/VB568NRg3K
The response rates are close. The durability is not. OptiTROP-Lung06: first-line, PD-L1-negative, EGFR/ALK-negative nonsquamous NSCLC. Sac-TMT + pembrolizumab vs chemotherapy + pembrolizumab: • Primary BICR-PFS: 15.0 vs 5.7 months; HR 0.49; P<0.0001 • ORR: 50.2% vs 47.3% • Median response duration: 13.6 vs 6.8 months • Grade ≥3 TEAEs: 47.6% vs 60.6% OS is immature, and median follow-up is only 9.7 months. Could replacing conventional chemotherapy with a TROP2 ADC improve the durability of first-line disease control? Longer follow-up will be crucial. @StephenVLiu @CharuAggarwalMD @myESMO @OncoAlert #OptiTROPLung06 #ESMO26 #LCSM
Sacituzumab tirumotecan (sac-TMT) plus pembrolizumab (P) versus chemotherapy (chemo) plus pembrolizumab (P) as first-line (1L) treatment for PD-L1-negative advanced non-squamous (nsq) NSCLC: Randomized phase 3 OptiTROP-Lung06 study Caicun Zhou (CN) #ESMO2026 https://t.co/p4dZoOiEGI
Can we be Opti-mists about improving the outcome of the poorest prognosis subset of our patients w PD-L1 negative advanced NSCLC? Based on OptiTROP-Lung06 we should be! Sac-TMT/pembro sacked chemo/IO easily with much improved PFS, clear OS trends, better/different tox- only 5% discontinuation rate! (But note mucositis as common AE)
A new SoC in a patient population with negative PD-L1 expression NSCLC. Sac-TMT + Pembro >>> Chemo + Pembro #ESMO26 #LCSM https://t.co/GDvUjtOldv
🚨 ESMO 2026 × NEJM: Is chemotherapy losing its place in first-line lung cancer? 🔥 OptiTROP-Lung06 delivers a striking Phase III result in PD-L1–negative advanced nonsquamous NSCLC! Sacituzumab tirumotecan + pembrolizumab vs chemo + pembrolizumab: 📊 Median PFS: 15.0 vs 5.7 months 🔥 51% lower risk of progression/death (HR 0.49) ✅ Grade ≥3 AEs: 47.6% vs 60.6% ⚠️ OS remains immature. The big question: Could TROP2-ADC + immunotherapy replace platinum chemotherapy in first line? Published simultaneously in NEJM during #ESMO26. @my_esmo @ESMO_open @ASCO @oncoalert #LungCancer #NSCLC #ESMO26
Another impressive set of results with sac-TMT! #ESMO26 https://t.co/DbdSusbS6f
OptiTROP-Lung06 now @NEJM after #ESMO26 presentation showing Sac-TMT (TROP2 ADC) + pembro superior to standard chemotherapy + pembro. #ESMOAmbassadors @myESMO https://t.co/AWr8vi6VvR
Zhou: Optitrop-Lung06 chemo/io vs sacTMT/Pembro in PDL1 neg. Impressive PFS difference. Similar second line use. Deeper responses and double duration of response. Less tox except more stomatitis. Access is a major issue! #LCSM #ESMO26 https://t.co/Rqm8vvYalR
OptiTROP-Lung06; sacTMT v chemoIO(KN189); n455; open label; PFS HR 0.49; nearly 10m longer mPFS; females magnitude of benefit less; same ORR but double mDOR; tox profile looks interest in stomatitis + ocular. #ESMO26 https://t.co/ygTCgtwpzJ
🔥 Impressive results from OptiTROP-Lung06 at #ESMO26! Prof. Zhou presents phase III data in first-line PD-L1 TPS <1% advanced non-squamous NSCLC. 💥 Sac-TMT + pembrolizumab vs chemo + pembrolizumab: ✅ PFS: 15.0 vs 5.7 months HR 0.49 (95% CI 0.36–0.65), p<0.0001 📈 Encouraging OS trend: HR 0.58 (95% CI 0.38–0.88), but OS remains immature and exploratory at this interim analysis. A clearly positive PFS result and a promising OS signal. Longer follow-up and safety data will be essential to define its clinical impact. #ESMOAmbassadors #LungCancer #NSCLC #ADC
🫁 #ESMO2026 OptiTROP-Lung06: sac-TMT + pembro vs chemo + pembro in PD-L1-negative NSCLC in china. High never smoker (30%) and male (60%) popn. Promising PFS: 15.0 vs 5.7m (HR 0.49). OS immature. Global data awaited Sac-TMT is also in clinical trials at @NHSBartsHealth https://t.co/xL5qviAYhn
Context: per the baseline characteristics slide, 72.1% of patients in each arm were male and 34.5% vs 37.2% were never smokers.
#ESMO26 Dr. Caicun Zhou presents OptiTROP-Lung06: 1L Sac-TMT (TROP2 ADC) + pembro vs chemo + pembro in non-squamous NSCLC. PFS 15m vs 5.7m (HR 0.49). OS immature but 1y rate 78% vs 66% (HR 0.58). mDOR 13.6m vs 6.8m. TEAEs leading to d/c of drug 6% with Sac-TMT 14% with chemoIO. https://t.co/NuvZZ9S3EM
🆙#ESMO26 Proffered Paper I: #LCSM Mets 🔥OptiTROP-Lung06: Sacituzumab Tirumotecan (Sac-TMT) Plus Pembrolizumab (P) Versus Chemotherapy (Chemo) Plus Pembrolizumab (P) as First-Line (1L) Treatment for PD-L1-Negative Advanced Non-Squamous (Nsq) NSCLC: Randomized Phase 3 Study 🎙️Dr. Caicun Zhou 🔢LBA66 🎯Met Primary Endpoint: BICR-PFS 15.0 vs 5.7mo (HR 0.49, p<0.0001; n=455) 🎯OS Immature, Favorable Trend (HR 0.58) 🎯Grade≥3 TEAEs 47.6% vs 60.6%; Grade≥3 Stomatitis 2.2% ☑️NCT06711900 🔗 https://t.co/uGHKJfjhvW @OncoAlert @Larvol @myESMO @IASLC
#ESMO26 | OptiTROP-Lung06 Concomitant NEJM publication Such a clear benefit over standard chemo-IO in PD-L1-negative NSCLC is impressive, especially with fewer severe AEs. OS is still immature, but sac-TMT + pembro looks like a strong contender to change first-line treatment https://t.co/E3UdsILlyn https://t.co/fayTGhSChB
🔥OptiTROP-Lung06: Sac-TMT + pembrolizumab vs chemo + pembrolizumab in PD-L1-negative advanced NSCLC 🆙 @NEJM #ESMO26 ☑Phase 3 RCT; N=455; PD-L1<1% nonsquamous NSCLC; mFU 9.7 mo 🎯mPFS 15.0 vs 5.7 mo (HR 0.49, p<0.001); mOS HR 0.58; grade ≥3 AEs lower with sac-TMT (47.6% vs 60.6%) 🎙Dr. Fei Zhou & Dr. Caicun Zhou #LCSM @OncoAlert @Larvol @IASLC https://t.co/id5CQipESy
#ESMO26 | OptiTROP-Lung06 PD-L1 <1% non-sq NSCLC: Sac-TMT + pembro vs platinum/pem + pembro 🔹 PFS: 15 vs 5.7 mo (HR 0.49) 🔹 DoR: 13.6 vs 6.8 mo 🔹 OS: HR 0.58 (immature) 🔹 ≥G3 AEs: 47.6% vs 60.6% Strong results vs contemporary chemo-IO. https://t.co/mT1aoETKPQ
⭐️How do we improve outcomes for #lungcancer patients with PDL1 < 1% in the 1L setting? This may be addressed with the following two approaches 1⃣Sacituzumab tirumotecan (sac-TMT) plus pembrolizumab (P) versus chemotherapy (chemo) plus pembrolizumab (P) as first-line (1L) treatment for PD-L1-negative advanced non-squamous (nsq) NSCLC: Randomized phase 3 OptiTROP-Lung06 study 2⃣First-line (1L) olomorasib + chemoimmunotherapy (chemo-IO) in KRAS G12C-mutant NSCLC: Updated results from the LOXO-RAS-20001 and SUNRAY-01 trials. These are separate strategies (ADC vs TKI), but both address a fundamental need which is combination approaches for certain subsets of 1L NSCLC. @lcsmchat @OncoAlert @OncLive @Onco_Nexus @LungCancerEu @Lung_Cancers @LungCancerRx @MedwatchHQ @YoungLungCancer @KRASKickers
Posted on October 24, before the presentation.
5/ OptiTROP-Lung06 (LBA66), Oct 25, 10:53 CET Sac-TMT + pembro vs chemo + pembro, 1L PD-L1-negative nonsquamous NSCLC. PFS met per Kelun-Biotech. Can a TROP2 ADC replace the platinum doublet alongside IO? @LungCancerRx @OncoAlert @oncodaily https://t.co/XWMc6SJ3gy
Posted on October 23, before the presentation.
Phase III OptiTROP-Lung06 meets primary endpoint. First-line sacituzumab tirumotecan (sac-TMT, Trop2 ADC) + pembro vs chemo + pembro in PD-L1 negative non-squamous NSCLC. Sac-TMT + pembro had superior PFS with OS trend. Will ADCs push out chemo? https://t.co/kQiRMDEYN9
Posted on July 15, 2026, after Kelun-Biotech's topline announcement and before any numbers were released.
ついに肺癌にもADC+ICI時代が到来しますかね…結果が楽しみ😊 https://t.co/bSY2cErwlK
Posted on July 15, 2026, after Kelun-Biotech's topline announcement and before any numbers were released.
JUST IN via @PRNewswire: PhIII trial of OptiTROP-Lung06 with SAC-TMT (Trop-2 @Merck ADC)+ Pembro vs SOC chemo/IO shows PFS and OS superiority for this new regimen in PDL-1 NEGATIVE non-small cell lung cancer. Slowly but surely, convention cytotoxic chemotherapy is being relaced by ADCs... https://t.co/SkbRI7avSM
Context: Kelun-Biotech's July 14 topline release reported that the primary PFS endpoint was met with a positive OS trend. At ESMO 2026, OS data were immature (HR 0.58, 95% CI 0.38–0.88), a descriptive analysis at the PFS interim analysis.
Nothing like a lung cancer World Cup semifinal press release- sac-TMT/pembro beats chemo/IO for st4 PD-L1 neg nonSQ NSCLC (given prior positive studies sac-TMT now has scored 3 spectacular goals!) This sets up a really interesting #lcsm first line World Cup finals match between ivonescimab and sac-TMT! Might need some penalty kicks for a decision.. Which will deliver the trophy of FDA approval/ larger market share - and most importantly improved patient outcomes until the next challenger shows up? Hope we wont need to wait 4 years!
Posted on July 15, 2026, after Kelun-Biotech's topline announcement and before any numbers were released.
OptiTROP-Lung06 asked whether replacing pemetrexed-platinum chemotherapy with sacituzumab tirumotecan, a TROP2-directed antibody-drug conjugate, improves outcomes when combined with pembrolizumab as first-line treatment for PD-L1-negative nonsquamous NSCLC. Pembrolizumab plus pemetrexed-platinum is the standard first-line regimen in this population. The trial is sponsored and funded by Sichuan Kelun-Biotech (Chengdu, China); Merck (MSD) makes pembrolizumab and holds sac-TMT rights outside Greater China. Results were presented by Caicun Zhou, MD, at ESMO 2026 (LBA66, Proffered paper 1: NSCLC, metastatic, October 25, 2026), with Melissa L. Johnson, MD, as invited discussant, and published in NEJM the same day.
Randomized 1:1, open-label, multicenter phase 3 in China (NCT06711900; 81 registered sites); 229 vs 226 patients. Stratified by sex, ECOG PS (0 vs 1) and stage (IIIB/IIIC vs IV).
Untreated locally advanced (IIIB/IIIC) or metastatic nonsquamous NSCLC; PD-L1 TPS <1% by IHC 22C3 (central lab); no sensitizing EGFR or ALK alteration; ECOG PS 0–1. Median age 63; 72.1% male; 91.6% stage IV; never smokers 34.5% vs 37.2%.
Sac-TMT 4 mg/kg Q2W + pembrolizumab 400 mg Q6W vs pemetrexed 500 mg/m² + carboplatin AUC 5 or cisplatin 75 mg/m² Q3W (up to 4 doses, then pemetrexed maintenance) + pembrolizumab 400 mg Q6W. Pembrolizumab for up to 18 cycles; treatment until progression or unacceptable toxicity.
Primary: PFS by BICR (RECIST 1.1). Secondary: OS, investigator-assessed PFS, ORR, DCR, DOR, safety.
Presenter: Caicun Zhou, MD (Shanghai East Hospital, Tongji University), national lead principal investigator. NEJM first author: Fei Zhou, MD. Invited discussant: Melissa L. Johnson, MD (SCRI).
Prespecified interim PFS analysis; data cutoff June 9, 2026; median follow-up 9.7 months. OS reported descriptively at this analysis.
OptiTROP-Lung06 (NCT06711900) is a randomized, open-label phase 3 trial run in China by Sichuan Kelun-Biotech. It compared sacituzumab tirumotecan (sac-TMT), a TROP2-directed antibody-drug conjugate, plus pembrolizumab with pemetrexed-platinum chemotherapy plus pembrolizumab as first-line treatment in 455 patients with advanced nonsquamous NSCLC, PD-L1 TPS below 1% and no EGFR or ALK alteration.
At the prespecified interim PFS analysis (data cutoff June 9, 2026; median follow-up 9.7 months), the primary endpoint was met: median PFS by blinded independent central review was 15.0 vs 5.7 months, HR 0.49 (95% CI 0.36–0.65). ORR was similar (50.2% vs 47.3%) but median duration of response was 13.6 vs 6.8 months. Results were published simultaneously in NEJM.
Not yet shown. Overall survival is a secondary endpoint and the data are immature: 36 vs 55 deaths, medians not reached, HR 0.58 (95% CI 0.38–0.88), reported as a descriptive analysis at the PFS interim analysis. The 12-month OS rate was 77.6% vs 66.4%.
No. Sacituzumab tirumotecan is not approved by the FDA or the European Medicines Agency for any indication. In China (NMPA) it is approved in four other indications (previously treated triple-negative breast cancer, EGFR-mutant NSCLC after EGFR-TKI in two settings, and pretreated HR+/HER2− breast cancer). First-line sac-TMT plus pembrolizumab for PD-L1-negative NSCLC is investigational everywhere. Merck (MSD) holds sac-TMT rights outside Greater China. It is a different drug from sacituzumab govitecan (TRODELVY).
Grade ≥3 treatment-emergent adverse events occurred in 47.6% vs 60.6% of patients, and 5.7% vs 14.2% discontinued a study drug because of an adverse event. Sac-TMT brought stomatitis (51.1% any grade, 2.2% grade 3) and ocular surface toxicity (13.5%, all grade 1–2); pneumonitis, including ILD, occurred in 10.5% vs 13.7%.
Yes. All 81 sites listed on ClinicalTrials.gov are in China. Several physicians flagged the China-only population and asked for global data; one noted results have been similar in Asian and other populations (see Discussion Threads and Physician Reactions).