ARTEMIS-008 at a Glance
Design
Phase III, randomized, open-label: risvutatug rezetecan 8.0 mg/kg IV q3w versus topotecan in advanced/relapsed SCLC after prior platinum-based therapy; OS primary endpoint. (Hansoh press release; OncLive)
Efficacy вАФ pre-planned interim analysis
At the pre-planned interim OS analysis (192 of 256 planned events, 75% information fraction; DCO June 6, 2026; median follow-up 12.2 months): median OS 18.5 vs 10.3 months, a 54% reduction in the risk of death (HR 0.46); BICR PFS HR 0.33; ORR 58.3% vs 12.6%. Medians at an interim this early can move with follow-up. (WCLC 2026 presented slides on this page; OncLive)
Safety
Interstitial lung disease in 11.7% is the signal KOLs flagged; overall treatment-related severe AEs were fewer than with topotecan. (WCLC 2026 presentation via verbatim KOL posts)
Regulatory status
⚠️ Investigational. FDA Breakthrough Therapy designations (r/r ES-SCLC and r/r osteosarcoma), EMA PRIME (r/r ES-SCLC), orphan designations in the US and Japan; Hansoh plans a China submission, GSK leads ex-China development. (Hansoh PR; Targeted Oncology)
KOL pulse
The physicians captured verbatim on this page weighed striking interim OS and response numbers against the 11.7% ILD signal and China-only enrollment — with sequencing versus DLL3-directed therapy the open question across the threads.
KOLs Discussing ARTEMIS-008
Key Slides & Data
What Physicians Said
Another wow curve. Ris-rez improves OS over topotecan, mOS 18.5m (!) vs 10.3m, OS HR 0.46, 1y OS rate 65% vs 43%. Good control arm OS and curves that split early and widen. The ADC era clearly here. #WCLC26 https://t.co/QMat6K2JS7
Important #WCLC26 result in relapsed SCLC: ARTEMIS-008. Risvutatug rezetecan (Ris-Rez) vs topotecan after first-line platinum-based ± ICI therapy: https://t.co/FCzeedddoe
ARTEMIS-008 Ris-Rez (B7H3 ADC) 2L SCLC Ph3 open label v Topo вЬЕрЯФЉOS 18m v 10m, HR 0.46вЭЧпЄП вЬЕрЯФЉPFS, HR 0.33вЭЧпЄП вЬЕрЯФЉORR 58 v 12% рЯФЇрЯФљTRAE but 11% pneumonitis рЯ§Ф B7H3 ADC = Future Standard of Care OS identical to Tem-Peli вЪ†пЄП pneumonitis вЪ†пЄП China only data #WCLC26 https://t.co/sznEdGsy5B
рЯЗ®рЯЗ≥ phase 3 ARTEMIS-008 trial comparing Ris-Rez versus topotecan for the treatment of relapsed SCLC. Impressive 18.5 months overall survival with HR 0.46, but higher ILD incidence 11.7% and Gr 3-4 AEs. Solid results to be confirmed in ongoing global studies. #LCSM #WCLC26 @IASLC https://t.co/5vVp6x8LPC
ARTEMIS-008; Ris-Rez B7-H3 ADC; P3 RCT in relapsed SCLC v topo; n461; 87% ES-SCLC; WOW OS HR 0.46 in all subgroups :ORR 13%v 58%; ILD in 12% (4.9% in Tam-Peli TAISHAN 302);Await ex China global trial #WCLC26 https://t.co/HaS3TbnIH7
Another B7H3, Ris-Rez, with impressive OS (18.5m v 10.3m HR 0.46) in #SCLC compared to topotecan. High risk of AE w/ ILD (11%) makes this #ADC a bit less desirable. Global study hopefully will help to inform the frequency of these AEs in a broader population @IASLC #WCLC26 #lcsm https://t.co/ojJXkEbTf7
TAISHAN-302 (Zhang L, et al) and ARTEMIS-008 (Wang J, et al) #WCLC26 @IASLC discussion by @Annechiangmd Take: Both phase 3 trials hit their primary OS endpoint vs topotecan with the same HR (0.46). TAISHAN-302: mOS 13.3 mo at 9.2 mo follow-up. ARTEMIS-008: mOS 18.5 mo at 12.2 mo follow-up. ILD/pneumonitis is the key safety. Cross-trial caveats are real: Chinese-only population, ~30% non smokers. IMO the activity should be similar in non Chinese. #SCLC #LCSM
рЯЖЩ#WCLC26 #LCSM Plenary Session рЯФ•ARTEMIS-008: Risvutatug Rezetecan (a B7-H3-Directed ADC) Versus Topotecan in Relapsed SCLC: Primary Results of Phase 3 рЯОЩпЄПDr. Jie Wang рЯОѓPFS HR 0.33 (95% 0.25-0.42) рЯОѓOS HR 0.46 (95% 0.35-0.62) рЯФҐPL02.04 вШСпЄПNCT06498479 рЯФЧ https://t.co/JvkpEBLlSo @OncoAlert @Larvol @IASLC
What a day for #SCLC! Two positive phase III ADC trials today at #WCLC26 ARTEMIS-008 and TAISHAN-302вАФ and this may be just the beginning. Look at the pipeline рЯСЗ The ADC era has finally arrived in SCLC. Bye bye, topotecan! рЯЪА https://t.co/fjXfmHC7KL
Dr. Jie Wang presents results from phase III ARTEMIS-008 trial of risvutatug rezetecan (ris-rez), a B7-H3 antibody drug conjugate (topo-1 payload) vs topotecan in relapsed SCLC at #WCLC26. Included pts with SCLC progressed after 1 line of platinum-based chemotherapy with a 1:1 randomization to ris-rez 8mg/kg q3w vs standard topotecan. Again - 30% of pts had no smoking history - different biology and expect these patterns globally in the coming years.
#WCLC26 | ARTEMIS-008 (pre-planned interim) рЯІђ Ph3: Risvutatug Rezetecan (Ris-Rez), a B7-H3вАУdirected TOP1 ADC, vs topotecan in relapsed SCLC after 1L platinum ¬± IO (n=461; ~81% prior PD-(L)1) рЯПЖ OS: 18.5 vs 10.3 mo; HR 0.46 (95% CI 0.35вАУ0.62, p<0.0001) рЯУЙ PFS: 7.2 vs 3.0 mo; HR 0.33 (BICR) рЯОѓ ORR: 58.3% vs 12.6% | DCR: 90.4% vs 60.2% рЯФО OS benefit was consistent across predefined subgroups, including CTFI <90/вЙ•90 days and baseline brain metastases рЯЫ°пЄП GвЙ•3 TRAEs: 60.9% vs 78.2% вЪ†пЄП ILD: 11.7% vs 1.9%; GвЙ•3: 3.9% vs 0.9%; no G4/5 ILD рЯСЙ Large OS/PFS benefit with higher response rates. Ris-Rez emerges as another potential new standard for relapsed SCLC.
ARTEMIS-008 at #WCLC26 In relapsed SCLC, the B7-H3 ADC risvutatug rezetecan (Ris-Rez) significantly improved OS versus topotecan in the phase III ARTEMIS-008 trial. Median OS: 18.5 vs 10.3 months HR 0.46 (95% CI 0.35вАУ0.62), P<0.0001 PFS and response outcomes also consistently favored Ris-Rez @OncoAlert @ManuelDomine @OpenMedKate
And now we have 2nd ADC in second line SCLC . ARTEMIS 008. Ris-Rez ( B7-H3 targeted ADC ) . Question will be how to choose from this ? Suddenly too many options in second line SCLC @IASLC @StephenVLiu @RManochakian @OncoAlert https://t.co/VyDbRIlBb2
About the ARTEMIS-008 Trial
ARTEMIS-008 delivered what Hansoh describes as the first positive phase III OS result for a B7-H3-directed ADC (topline announced July 10, 2026; interim analysis presented at the WCLC 2026 Presidential Symposium). Risvutatug rezetecan couples a fully human anti-B7-H3 antibody to a topoisomerase-inhibitor payload; Hansoh developed the asset and GSK licensed global rights outside greater China in 2023.
The same session carried TAISHAN-302, the second positive B7-H3 ADC phase III in the identical setting — instantly reframing the WCLC debate from whether the class works to how it will be sequenced against DLL3-directed therapy, and which asset's profile (activity vs ILD signal, global vs China data) carries the class forward.
Trial Methodology & Results
Study Design
Phase III, randomized, open-label: Ris-Rez 8.0 mg/kg IV q3w vs topotecan; primary endpoint OS. (OncLive; Hansoh PR)
Population
Advanced or relapsed SCLC after prior platinum-based therapy; enrolled in China. (Hansoh PR; KOL discussion)
Endpoints
OS primary — read out at a pre-planned interim (192/256 events, DCO June 6, 2026, median follow-up 12.2 months); PFS and response among key secondaries; safety consistent with prior findings per the sponsor. (Presented slides; Hansoh PR)
Context
Presented WCLC 2026 Presidential Symposium alongside TAISHAN-302 — two positive B7-H3 ADC phase IIIs in one session.
Overall survival вАФ pre-planned interim analysis
At the pre-planned interim OS analysis (192 of 256 planned events, 75% information fraction; DCO June 6, 2026; median follow-up 12.2 months, with only about a third of Ris-Rez-arm events accrued): median OS 18.5 versus 10.3 months with topotecan, a 54% reduction in the risk of death (HR 0.46). An interim median this early can shift with longer follow-up; the final analysis at 256 events is pending. (WCLC 2026 presented slides on this page; OncLive)
Interim OS 18.5 vs 10.3 mo · HR 0.46 · DCO 06-Jun-2026Source: WCLC 2026 presented slides · OncLive ↗
Response, PFS and the ILD signal
ORR 58.3% vs 12.6% and BICR PFS HR 0.33 (investigator-assessed 0.35). The flagged toxicity: interstitial lung disease in 11.7% of Ris-Rez patients — the number physicians repeatedly cited as the watch-item — against overall fewer severe treatment-related AEs than topotecan. (WCLC 2026 presentation via the verbatim physician captures on this page, incl. @M_Torasawa)
ORR 58.3% vs 12.6% · BICR PFS HR 0.33 · ILD 11.7%Source: WCLC 2026 presentation (verbatim KOL captures) ↗
WCLC 2026: Live KOL Reaction
Physician posts about this trial captured live during the IASLC 2026 World Conference on Lung Cancer (Seoul, September 12–15). Quotes are verbatim; each card links to the original post. Last updated 2026-09-15.
We now have TWO studies showing B7-H3 ADCs vastly superior to standard topotecan for relapsed SCLC: tam-peli and ris-rez. These studies were different - different agents, different baseline demographics of pts, etc - but the outcomes were similar, control arms performed similarly. These trials reinforce each other. Looking forward to global studies and to first-line studies. The ADC era soundly here for SCLC and these will replace chemotherapy across lines, in my opinion. #WCLC26
рЯЖЩ#WCLC26 #LCSM Plenary Session рЯФ•ARTEMIS-008: Risvutatug Rezetecan (a B7-H3-Directed ADC) Versus Topotecan in Relapsed SCLC: Primary Results of Phase 3 рЯОЩпЄПDr. Jie Wang рЯФҐPL02.04 вШСпЄПNCT06498479 рЯФЧ https://t.co/icbDk1Zjnh @OncoAlert @Larvol @IASLC https://t.co/vysdlSeQpe https://t.co/pffDuSzaSF
1/2 рЯЪ® Several #WCLC26 Presidential Symposium trials already have topline press releases рЯСА рЯЩМ ARTEMIS-008 | Risvutatug Rezetecan вАҐ Phase 3 in relapsed SCLC вАҐ Met the primary endpoint of OS vs. topotecan вАҐ Statistically significant and clinically meaningful OS benefit! рЯФЧ https://t.co/WavE0BuSbb рЯ§¶вАНвЩВпЄП EVOKE-03 / KEYNOTE-D46 | Sacituzumab Govitecan + pembrolizumab вАҐ 1L PD-L1 TPS вЙ•50% metastatic NSCLC вАҐ PFS improvement did not reach statistical significance вАҐ Study was discontinued after an eDMC review рЯФЧ https://t.co/t0DcvrKJmz
Two B7-H3 ADCs presented at #WCLC26 produced very encouraging results in relapsed SCLC: ARTEMIS-008 (Ris-Rez) and TAISHAN-302 (Tam-Peli). We put them side by side in a descriptive cross-trial comparison. https://t.co/yjHAxmq7S1
Dr. Jie Wang presents the ARTEMIS-008 Phase 3 results of Ris-Rez compared to topotecan in 2L+ ES-SCLC at @iaslc #WCLC26. Ris-Rez significantly improved OS, PFS, and ORR. ILD rate 11.7%. Fewer patients with platinum resistant disease (<90d) compared to Tam-Peli. Similar to YL201, China only study, but this study again demonstrates OS improvement over topotecan with a B7-H3 ADC. While highly effective initially, ADCs are prone to acquired resistance and cumulative myelosuppression that need to be proactively addressed. @SclcSMASHERS @LUNGevity @lungoncdoc @StephenVLiu @RManochakian @LauraAlderMD @NaglaAKarimMD @BrunaPellini @LungCancerEu @OncodailyLung @OncoAlert @OncLive
ADC have arrived in second line SCLC . Many options for patients now. Rapidly evolving field . Nice discussion to summarize both Taishan-302 and Artemis 008 . @IASLC @StephenVLiu @FordePatrick @CharuAggarwalMD @DrRiyazShah @LauraAlderMD https://t.co/Xm9cOOk6cO
рЯФ• #WCLC26 #ARTEMIS008 рЯОѓ Riz Rez (risvutatug rezetecan ) B7-H3 ADC, vs topotecan in relapsed #SCLC: Phase 3 study вЦґпЄП OS: 18.5 vs 10.3 months; HR, 0.46 вЦґпЄП PFS: 7.2 vs 3.0 months; HR, 0.33 вЦґпЄП Higher ORR and DCR .рЯСЙрЯПљMore positive data вАФsupporting development of B7-H3вАУdirected ADCs in relapsed SCLC. #lcsm @SclcSMASHERS @IASLC
#WCLC26 | TAISHAN-302 vs ARTEMIS-008 Two B7-H3 ADCs, identical OS HR 0.46 vs topotecan. Ris-Rez: mOS 18.5 mo; Tam-Peli: 13.3 mo, but cross-trial comparison is confounded by baseline risk. Class effect clear; winner still unknown.@OncoAlert https://t.co/0eIjOWzhat
Terrific discussion by #AnneChang at #WCLC2026 on ADCs in SCLC @IASLC TAISHAN-302 and ARTEMIS-008 both show clear OS/PFS benefit over topotecan, pointing to a possible new standard. Manageable toxicity overall Looking forward a bright ADC future рЯТ° https://t.co/NKTnmMi1pL
Two B7-H3 ADCs. Two positive phase 3 trials. One striking signal in relapsed SCLC. At WCLC 2026, TAISHAN-302 and ARTEMIS-008 both showed a major OS benefit over topotecan вАФ remarkably, with an OS HR of 0.46 in each trial. вАҐ TAISHAN-302 вАФ Tam-Peli: OS 13.3 vs 9.4 mo; PFS 7.4 vs 2.8 mo; ORR 59.1% vs 9.7% вАҐ ARTEMIS-008 вАФ Ris-Rez: OS 18.5 vs 10.3 mo; PFS 7.2 vs 3.0 mo; ORR 58.3% vs 12.6% Both also showed substantially less grade вЙ•3 thrombocytopenia than topotecan. Important: this is a cross-trial comparison only. Different populations, study conduct and safety definitions mean we should not infer superiority of one ADC over the other. B7-H3 has arrived in relapsed SCLC. WCLC 2026 вАҐ PL02.03 TAISHAN-302 вАҐ PL02.04 ARTEMIS-008 #MVOnco #SCLC #B7H3 #ADC #LungCancer #WCLC2026 #Oncology #ThoracicOncology
рЯЂБ B7-H3 ADCs continue to reshape second-line SCLC. #wclc26 ARTEMIS-008 showed a significant OS benefit with risvutatug rezetecan (Ris-Rez) vs topotecan in relapsed SCLC: вАҐ OS: 18.5 vs 10.3 months, HR 0.46 вАҐ PFS: 7.2 vs 3.0 months, HR 0.33 вАҐ ORR: 58.3% vs 12.6% вАҐ Grade вЙ•3 TRAEs: 60.9% vs 78.2% The benefit was consistent across subgroups, including patients previously treated with PD-(L)1 inhibitors. Together with other ph3 data in relapsed SCLC, these results strengthen B7-H3 ADCs as a potential new treatment paradigm. #C√°nCare #SCLC #LungCancer #ThoracicOncology #ADC #B7H3
#WCLC26 вАУ A turning point for relapsed #SCLC? Two B7-H3 ADC trials vs topotecan: -TAISHAN-302: OS 13.3 vs 9.4mo (HR 0.46), ORR 59.1% vs 9.7% -ARTEMIS-008: OS 18.5 vs 10.3mo (HR 0.46), PFS 7.2 vs 3.0mo (HR 0.33) Big signals вАФ potential new standard emerging @OncoAlert @Larvol https://t.co/jenXMESTTV
Impressive PFS with Ris-Rez in relapsed SCLC: 7.2 vs 3.0 mo, HR 0.33. But cross-trial comparisons with tarlatamab require caution. Different control arms and populations matter. #WCLC26 @IASLC @OncoAlert https://t.co/G9pyLERQ6I
TAISHAN-302 (Zhang L, et al) and ARTEMIS-008 (Wang J, et al) #WCLC26 @IASLC Take: Both phase 3 trials hit their primary OS endpoint vs topotecan with the same HR (0.46). TAISHAN-302: mOS 13.3 mo at 9.2 mo follow-up. ARTEMIS-008: mOS 18.5 mo at 12.2 mo follow-up. ILD/pneumonitis is the key safety. Cross-trial caveats are real: Chinese-only population, ~30% non smokers. IMO the activity should be similar in non Chinese. #SCLC #LCSM
Congratulations to my friend Dr. Jie Wang on a wonderful #WCLC26 presentation on ris-rez in SCLC. https://t.co/2zmq2Fru9v
ARTEMIS-008: B7-H3 delivers in relapsed SCLC. 🎯 Risvutatug rezetecan (Ris-Rez), a B7-H3–directed ADC, went head-to-head with topotecan in phase III — and improved every major efficacy endpoint. 🔹 OS: 18.5 vs 10.3 months | HR 0.46 🔹 PFS: 7.2 vs 3.0 months | HR 0.33 🔹 ORR: 58.3% vs 12.6% 🔹 DCR: 90.4% vs 60.2% 🔹 Grade ≥3 thrombocytopenia: 13.9% vs 59.7% The message is hard to miss: longer survival, deeper disease control, and less severe hematologic toxicity than topotecan. Could B7-H3 become one of the defining targets in relapsed SCLC? ARTEMIS-008 | WCLC 2026 #MVOnco #ARTEMIS008 #RisRez #B7H3 #SCLC #LungCancer #ADC #WCLC2026 #MedicalOncology
Especially after ARTEMIS-008 and TAISHO-302, MRI surveillance looks like an increasingly attractive option in SCLC—potentially avoiding PCI without compromising survival. #WCLC26 @OncoAlert @OncologyMarwarD @Larvol https://t.co/o4valulxkJ
#WCLC26 | ARTEMIS-008 Ris-Rez improved OS (18.5 vs 10.3 mo; HR 0.46) and PFS (7.2 vs 3.0 mo; HR 0.33) vs topotecan in relapsed SCLC. Another strong phase III signal for B7-H3 ADCs. How should we interpret this alongside TAISHAN-302? https://t.co/VRYS2dQXvH
B7 H3 may be changing the outlook for relapsed small cell lung cancer. In the Phase III ARTEMIS 008 trial, a B7 H3 directed antibody drug conjugate produced a striking survival advantage over topotecan. OS 18.5 vs 10.3 months PFS 7.2 vs 3.0 months ORR 58.3% vs 12.6% More options. More science. More hope. Educational information only.
🔥 #WCLC26 #ARTEMIS008 🎯 Riz Rez (risvutatug rezetecan ) B7-H3 ADC, vs topotecan in relapsed #SCLC: Phase 3 study ▶️ OS: 18.5 vs 10.3 months; HR, 0.46 ▶️ PFS: 7.2 vs 3.0 months; HR, 0.33 ▶️ Higher ORR and DCR .👉🏽More positive data —supporting development of B7-H3–directed ADCs in relapsed SCLC. #lcsm @SclcSMASHERS @IASLC
4/6 ARTEMIS-008 Another B7-H3 ADC, risvutatug rezetecan, versus topotecan. Here we already know something important: ✅ The phase III trial met its primary overall-survival endpoint, with a statistically significant and clinically meaningful benefit. At WCLC the question isn’t “did it work?” It’s how much did it work? HR, median OS, absolute benefit, PFS, durability and safety will matter.
ARTEMIS-008 improves OS, PFS, RR with ris-rez over topotecan in relapsed SCLC. Another standard of care over topotecan and practice changing where available. #WCLC26 https://t.co/b5j7a2xTws
#WCLC26 Ris-rez toxicity profile more favorable than topotecan control with G3+ TRAEs 61% vs 78%. ILD seen in 11.7% with ris-rez vs 1.9% with topoecan. Predominantly hematologic toxicities with ris-rez. https://t.co/7Zp0iCIP1Y
ARTEMIS-008 FAQ
What is the ARTEMIS-008 trial?
ARTEMIS-008 (NCT06498479) is a phase III randomized trial of risvutatug rezetecan (Ris-Rez, HS-20093) вАФ an investigational B7-H3-directed antibody-drug conjugate developed by Hansoh Pharma, with GSK holding development and commercialization rights outside greater China вАФ versus topotecan in patients with advanced or relapsed small-cell lung cancer after platinum-based therapy.
What did ARTEMIS-008 show at WCLC 2026?
At the pre-planned interim OS analysis (data cutoff June 6, 2026; median follow-up 12.2 months): median overall survival of 18.5 versus 10.3 months with topotecan, a 54% reduction in the risk of death (HR 0.46), BICR progression-free survival HR 0.33, and an objective response rate of 58.3% versus 12.6%. Per the sponsor, it is the first phase III trial to report an OS benefit for a B7-H3-directed ADC; the final analysis at 256 events is pending.
What is the main safety concern?
Interstitial lung disease occurred in 11.7% of patients on risvutatug rezetecan вАФ the toxicity physicians flagged most. Overall severe treatment-related adverse-event rates were otherwise lower than with topotecan, and the sponsor reported no new safety signals.
Is risvutatug rezetecan approved?
No. It is investigational, with FDA Breakthrough Therapy designations in relapsed/refractory extensive-stage SCLC and osteosarcoma, EMA PRIME designation, and orphan-drug designations in the US and Japan. Hansoh plans a regulatory submission in China; GSK leads development elsewhere.
How does ARTEMIS-008 compare with TAISHAN-302?
Both are positive phase III trials of investigational B7-H3 ADCs versus topotecan in relapsed SCLC, presented in the same WCLC 2026 Presidential Symposium. Cross-trial comparison is unreliable here in specific, documented ways: the populations differ (baseline brain metastases roughly 19% in ARTEMIS-008 versus 35% in TAISHAN-302) and the follow-up differs (median 12.2 versus 9.2 months at their respective interim cuts) вАФ so the 18.5- versus 13.3-month medians are not head-to-head comparable. Both trials enrolled in China, leaving global sequencing against DLL3-directed therapy the open question.
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Compiled and reviewed by the KOL Pulse research team, led by Brian Shields, Founder, KOL Pulse. Last updated September 14, 2026. Every statistic carries its source label in place; every quote is verbatim from the physician's own post.