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Q2 Preview: Expect Modest Q/Q Growth; Focus Remains on H2 Datasets for T1 SCLC and IL13/31
研报英文原文证据摘录
Q2 Preview: Expect Modest Q/Q Growth; Focus Remains on H2 Datasets for T1 SCLC and IL13/31
The global pipeline continues to mature and we expect this to become a bigger
driver of the valuation... Mgmt highlighted continued strong enrollment for the
ZL-1310 (DLL3 ADC, "Zoci") registrational study in second-line SCLC. The
company expects ~75% enrollment by YE/26 and full enrollment by Q1/27. While an
interim ORR analysis is planned once roughly 100 patients per arm have accrued at least
six months of follow-up, mgmt noted that regulators have prioritized building a robust
safety database and prefer full accrual before unblinding response data. Based on Phase
I experience, mgmt remains confident that Zoci can deliver a clinically meaningful
response advantage vs control, citing prior ORRs of ~60-70% in second-line patients
and ~45% in post-tarlatamab patients, including complete response(s). The company
expects to achieve overall survival outcomes comparable to or better than tarlatamab
while offering a more favorable safety profile. Mgmt emphasized that the ADC
mechanism may offer distinct advantages, including activity in high-volume disease and
brain metastases, with limited toxicity and broad applicability irrespective of target
expression levels.
In parallel, ZLAB is advancing front-line extensive-stage SCLC development and
expects to present the front line data at ESMO as a poster presentation,
supported by encouraging early data combining ZL-1310 with atezolizumab with or
without carboplatin. Mgmt continues to evaluate both chemotherapy-containing and
chemotherapy-free approaches, though discussions suggested increasing enthusiasm
for a chemo-sparing strategy given the potential for improved treatment duration,
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