Trial · for clinicians

ESMO 2026 in NEJM: HEALER (HER2+ breast) and OptiTROP-Lung06 (PD-L1-negative NSCLC)

11/2/2026 · 4 min read · updated 2 Nov 2026

Bottom line

Both trials hit PFS at interim analysis; OS immature in both. Both enrolled only in China. Neither regimen is approved by FDA, EMA or CDSCO yet.

Two phase 3 trials from ESMO 2026 (Madrid) that did not feature in the Presidential Symposia but went straight into NEJM. Both were run entirely in China, both challenge a long-standing first-line standard, and both report PFS at a prespecified interim analysis.

HEALER: anbenitamab + HB1801 vs THP, first-line HER2+ advanced breast cancer

Design

Phase 3, open-label, multicentre, China; 1:1.
Anbenitamab (KN026, HER2 biparatopic bispecific antibody) + HB1801 (albumin-bound docetaxel) vs docetaxel + trastuzumab + pertuzumab (THP).
n = 885 (445 vs 440).
Primary endpoint: PFS by blinded independent central review (BICR). ORR secondary.

Efficacy (interim; 401 events; median follow-up 21.0 mo)

24-mo PFS: 58.5% vs 34.4%.
HR for progression or death 0.46 (95% CI 0.37–0.56; P < 0.001).
ORR: 87.6% vs 73.4%.
OS: not reported as mature.

Safety

Grade ≥3 AEs: 45.9% vs 34.4%.
Grade ≥3 neutropenia (commonest): 13.1% vs 8.4%.
Fatal AEs: 2 patients in each arm.

Read

Large PFS gain over THP, the CLEOPATRA-era standard.
Two variables changed at once (bispecific in place of trastuzumab + pertuzumab, and albumin-bound in place of conventional docetaxel), so the effect cannot be attributed to the antibody alone.
No comparison with T-DXd + pertuzumab (DESTINY-Breast09).
Wait for OS and for data outside China before changing practice.

OptiTROP-Lung06: sac-TMT + pembrolizumab vs chemo + pembrolizumab, PD-L1 <1% non-squamous NSCLC

Design

Phase 3, open-label, 81 centres in China; 1:1.
Untreated locally advanced/metastatic non-squamous NSCLC, PD-L1 TPS <1% (central), no EGFR/ALK or other targetable alterations, ECOG 0–1.
Sacituzumab tirumotecan (sac-TMT, TROP2 ADC) 4 mg/kg q2w + pembrolizumab 400 mg q6w vs pemetrexed + platinum + pembrolizumab, then pemetrexed maintenance.
n = 455 (229 vs 226). Primary endpoint: PFS by BICR. OS secondary.

Efficacy (interim; data cut-off 9 Jun 2026; median follow-up 9.7 mo)

Median PFS: 15.0 vs 5.7 mo; HR 0.49 (95% CI 0.36–0.65; P < 0.001).
12-mo PFS: 51.1% vs 22.8%.
ORR: 50.2% vs 47.3%. Median DoR: 13.6 vs 6.8 mo.
PFS benefit held for TROP2-low (HR 0.49) and TROP2-high (HR 0.59) tumours.
OS immature, not formally tested: HR 0.58 (95% CI 0.38–0.88); 12-mo OS 77.6% vs 66.4%.

Safety

Grade ≥3 AEs: 47.6% vs 60.6%.
Fatal AEs: 2.2% vs 6.2%.
Dose reductions for AEs: 4.8% vs 19.9%.
Stomatitis common with sac-TMT, mostly grade 1–2.

Read

First phase 3 ADC + IO regimen to beat chemo-IO in driver-negative, PD-L1-negative non-squamous NSCLC, the subgroup that gains least from pembrolizumab.
Response rates were similar; the gain is in durability of response.
Short follow-up; OS signal is encouraging but descriptive.
No TROP2 selection needed on these data.

Relevance for India and other LMICs

Access: neither regimen is approved by FDA, EMA or CDSCO as of 2 Nov 2026. Both are China-developed (Kelun-Biotech for sac-TMT; JMT-Bio for anbenitamab), which may mean faster and cheaper regional access than Western ADCs, but nothing is confirmed for India.
Cost reality: in most Indian public-sector settings, first-line HER2+ MBC is still trastuzumab (often biosimilar) + taxane, with pertuzumab access limited. HEALER’s comparator (THP) is already beyond what many patients receive.
Population fit: all-China enrolment; Asian pharmacogenomics and toxicity profiles may be closer to Indian patients than Western-majority trials, but this is an assumption, not data.
Biomarkers: OptiTROP-Lung06 required central PD-L1 testing and exclusion of EGFR/ALK and other targetable drivers. Broad NGS remains unavailable for many Indian patients, a precondition before any of this applies.
Toxicity monitoring: ADC-related stomatitis and haematological toxicity need nursing and day-care capacity; plan before adoption.

For clinicians. Not medical advice; regimens discussed are not yet approved in India.

Sources

Educational summary, not medical advice. Opinions are labelled as such and are the author's own. Approvals and availability in India (CDSCO) may differ from the US/EU.

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