Zai Lab's Zoci Demonstrates 62.5% Intracranial ORR in Small Cell Lung Cancer, Global BLA Submission Planned for Late 2027
核心洞察
Zoci (搜索) achieved a 62.5% confirmed intracranial overall response rate at 1.6 mg/kg in extensive-stage small cell lung cancer (搜索), including four complete responses, with Grade ≥3 treatment-related adverse events at approximately 16%.
Global collaborations with Amgen and Boehringer Ingelheim are underway to evaluate Zoci (搜索) combinations with T-cell engagers in small cell lung cancer (搜索) and neuroendocrine carcinomas.
Zai Lab plans to submit its first global BLA to the FDA in late 2027, with the registrational Phase III DLLEVATE study on track to complete enrollment in the first half of 2027.
Zai Lab is positioning its lead oncology asset Zoci (搜索) as a potential backbone therapy in difficult-to-treat cancers, with new clinical data presented at the American Association for Cancer Research (AACR) annual meeting last month reinforcing the company's conviction in the drug's best-in-class profile. The company also announced global collaborations with Amgen and Boehringer Ingelheim, and confirmed plans to submit its first global Biologics License Application (BLA) to the U.S. Food and Drug Administration in late 2027.
"Zai Lab is at a pivotal moment. Since our founding, we have built a fully integrated R&D engine capable of taking assets from discovery through global registrational studies, with the ability to design and execute multiple central trials globally," said Ying Du, Chairperson and CEO of Zai Lab, during the company's first-quarter 2026 earnings call.
Intracranial Efficacy in Small Cell Lung Cancer (搜索)
In extensive-stage small cell lung cancer (搜索) (ES-SCLC), Zoci (搜索) demonstrated a confirmed intracranial overall response rate (ORR) of 62.5% and a best overall intracranial response rate approaching 69% at the go-forward dose of 1.6 mg/kg, including four complete responses. Grade 3 or higher treatment-related adverse events were reported at approximately 16%.
"Responses of this magnitude inside the brain in one of the most treatment-resistant tumor types in oncology are meaningful signals of differentiation," said Rafael Amado, President, Head of Global R&D and Chief Medical Officer at Zai Lab. "The safety data reinforced what we have consistently observed. This is a best-in-class profile."
The registrational Phase III DLLEVATE study is enrolling well and remains on track to complete enrollment in the first half of 2027, positioning the company for an interim analysis and potential accelerated approval submission next year.
Neuroendocrine Carcinoma (搜索) Results
In extrapulmonary neuroendocrine carcinoma (搜索), a setting with no established standard of care in the second line and beyond, Zoci (搜索) demonstrated a confirmed ORR of 38.2%. This compares favorably to currently used regimens, which typically show response rates of approximately 18% with limited durability. The company is actively engaging with regulators on a potential registrational path and is recruiting into an extension single-arm study. Depending on regulatory discussions, a registrational or confirmatory study could be initiated by year-end.
Global Collaborations with Amgen and Boehringer Ingelheim
Zai Lab announced global collaborations with Amgen and Boehringer Ingelheim to evaluate Zoci (搜索) in combination with T-cell engagers. The Amgen Phase I study, which includes a cohort of untreated patients with a triple combination of Zoci, IMDELLTRA, and Imfinzi, is already enrolling. The Boehringer Ingelheim study is expected to commence in the coming months.
"The scientific rationale is straightforward. Zoci (搜索) delivers rapid tumor debulking through targeted cytotoxicity, while T-cell engagers drive antigen-dependent immune-mediated killing," Amado explained. "The mechanisms are complementary, the toxicity profiles are expected to have limited overlap, and together, they have the potential to deepen and extend responses in ways neither mechanistic approach achieves alone."
Zai Lab is also evaluating Zoci (搜索) in combination with PD-L1 with or without chemotherapy in a Phase I study in first-line small cell lung cancer (搜索), with data expected later this year.
ZL-1503 in Atopic Dermatitis (搜索)
Beyond oncology, Zai Lab's IL-13 (搜索)/IL-31 (搜索) receptor alpha bispecific antibody ZL-1503 is advancing in a Phase I/Ib study for atopic dermatitis (搜索). Preclinical data presented at Immunology 2026 showed rapid and durable inhibition of both IL-13-driven inflammation and IL-31-mediated pruritus across disease models in nonhuman primates, with sustained effect following a single dose.
Initial Phase I data in healthy volunteers and atopic dermatitis (搜索) patients are expected in the second half of 2026. Amado noted that the company will be evaluating safety, pharmacokinetics to assess dosing interval, pharmacodynamics including phospho-STAT, and antidrug antibody data.
Commercial Performance and Financial Results
First-quarter 2026 total product revenue declined 6% year-over-year to $99.6 million, driven by lower ZEJULA sales, partially offset by continued growth from XACDURO and NUZYRA. ZEJULA performance was impacted by a shift in hospital utilization patterns following volume-based procurement for generic olaparib and incremental competitive pressure within the PARP inhibitor class.
VYVGART delivered double-digit volume growth year-over-year, offset by a 12% price reduction from NRDL renewal. Biologic penetration in the gMG maintenance setting remains around 15%. XACDURO saw strong underlying demand and hospital adoption expansion, though supply constraints are expected to persist through the remainder of the year.
R&D expenses increased 8% year-over-year for the quarter, driven by higher license fees and clinical trial-related expenses, partially offset by lower personnel costs. Loss from operations reached $69.4 million, representing a 23% increase year-over-year. The company ended the quarter with $761.3 million in cash.
Upcoming Catalysts
KarXT, described as the first novel mechanism for schizophrenia (搜索) in decades, launched in China in the second quarter of 2026 and has already been included in national treatment guidelines. The company also anticipates regulatory approval for Tivdak in cervical cancer in the coming months and for Tumor Treating Fields in locally advanced pancreatic cancer by year-end.
Vertex's Phase III RAINIER study of povetacicept in IgA nephropathy (搜索) achieved approximately a 50% reduction in proteinuria versus placebo and met all primary and secondary endpoints. Zai Lab plans to discuss regulatory requirements with the CDE for filing in China.
Management indicated that total product revenue is expected to remain under pressure for full-year 2026, with a return to growth anticipated in 2027.