Baili Pharma

Baili Pharma’s BL-M07D1 Enters Phase III in HER2-Mutant NSCLC, Challenging Keytruda Head-On

Baili Pharma has launched a head-to-head Phase III trial of BL-M07D1 versus Keytruda + chemo in first-line HER2-mutant NSCLC, a bold challenge to the current standard. Baili is also advancing Iza-Bren, an EGFR/HER3 ADC with strong Phase II results.

SDW Editor

— 2 min read

Baili Pharma’s HER2-targeting ADC BL-M07D1 has launched a randomized Phase III trial in first-line, treatment-naïve HER2-mutant advanced/metastatic non-squamous NSCLC (≈440 patients), comparing BL-M07D1 monotherapy to pembrolizumab (Keytruda) + platinum-doublet chemotherapy. With PFS by blinded independent review as primary endpoint, this head-to-head design could reshape standards in this biomarker-defined NSCLC cohort.

Trial snapshot

  • Design: Open-label, randomized, parallel-group Phase III (BL-M07D1-306)
  • Population: Adults (18–75) with treatment-naïve, advanced/metastatic HER2 functional mutations in non-squamous NSCLC; ECOG 0–1; measurable disease
  • Sample size: ~440 patients
  • Arms:
    • Experimental: BL-M07D1, 4.4 mg/kg IV, Day 1, q3w
    • Control: Pembrolizumab 200 mg IV q3w + pemetrexed 500 mg/m² + carboplatin (AUC 5) or cisplatin (75 mg/m²) q3w
  • Endpoints:
    • Primary: PFS (BICR, RECIST v1.1)
    • Secondary: OS, ORR, DoR, DCR, safety (TEAEs/TRAE), PK, immunogenicity
  • Key exclusions: prior HER2-targeted or toxin-linked ADC therapy, active ILD, uncontrolled arrhythmia, unstable CNS metastases
  • Trial (CTR): CTR20253668
  • Sponsor(s): Chengdu BailiDotter Biopharmaceutical Co., Ltd. / Sichuan Baili Pharmaceutical Co., Ltd. (part of Biokin Pharma / Baili Tianheng)

Companion program: Iza-Bren (BL-B01D1)

Alongside BL-M07D1, Baili Tianheng is developing Iza-Bren (BL-B01D1), an EGFR/HER3 bispecific ADC:

  • In first-line EGFR-mutant NSCLC, Iza-Bren + osimertinib achieved nearly 100% ORR and ~92% 12-month PFS.
  • As monotherapy in pretreated patients, Iza-Bren showed ~66% ORR, 12.5-month PFS, and ~80% 12-month OS.

Together, BL-M07D1 and Iza-Bren illustrate a dual-track ADC strategy: tackling HER2-mutant and EGFR-mutant NSCLC, positioning Baili as a contender across major oncogenic subsets.

Why this trial matters — analysis

  • Biomarker precision: HER2-mutant NSCLC represents a distinct, actionable subgroup. Targeted ADCs offer the potential for higher efficacy independent of PD-L1 or TMB, contrasting with immunotherapy.
  • Direct Keytruda challenge: By choosing pembrolizumab + chemotherapy as the comparator, Baili is signaling confidence that BL-M07D1 could displace a global standard.
  • ADC opportunity and risk: ADCs can deliver potent cytotoxics to tumor cells, but safety in thoracic cancers — especially ILD/pneumonitis — will be critical.
  • Strategic positioning: With both BL-M07D1 and Iza-Bren advancing, Baili Pharma appears intent on building a leadership position in driver-mutation lung cancer, moving ADCs from late-line salvage into the first-line setting.

What to watch next

  • Enrollment pace and geographic scope (China sites, possible U.S. expansion)
  • Interim analyses or DMC updates
  • ADC safety signals (ILD, cardiac events)
  • Results from BL-M07D1’s other Phase IIIs (breast, gastric) to shape label strategy

Takeaway

BL-M07D1’s Phase III represents a bold bid by Baili Pharma to challenge Keytruda head-on in first-line HER2-mutant NSCLC. Combined with promising Iza-Bren data in EGFR-mutant disease, the company is positioning itself as a serious ADC contender in oncogene-driven NSCLC.

Sources

  1. Chinese Clinical Trial Registry (CTR20253668)
  2. SinoDrugWatch. Iza-Bren (BL-B01D1) bispecific EGFR/HER3 ADC shows promise in EGFR-mutated NSCLC. 2025.

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