On September 14, 2026 Nanjing Leads Biolabs Co., Ltd. ("Leads Biolabs" or the "Company," Stock Code: 9887.HK) reported that updated Phase II data for opamtistomig (LBL-024), its proprietary PD-L1/4-1BB bispecific antibody, plus chemotherapy as first-line treatment for non-small cell lung cancer (NSCLC), were presented in an oral presentation at the 2026 World Conference on Lung Cancer (WCLC).
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The updated data demonstrated robust and durable antitumor activity across both squamous and non-squamous NSCLC, including high response rates in squamous NSCLC regardless of PD-L1 expression and deep, durable responses in PD-L1-positive non-squamous NSCLC. The findings further support the potential of opamtistomig’s differentiated dual-target mechanism to broaden the clinical benefit of immunotherapy in first-line NSCLC.
Highlights
Robust efficacy across NSCLC: As of July 1, 2026, 63 treatment-naïve patients had been enrolled, including 31 non-squamous and 32 squamous NSCLC patients. More than 90% had stage IV disease, and a considerable proportion had multiple metastases, including brain and liver metastases. PD-L1 TPS ≥1% was observed in only 35.5% of non-squamous and 43.8% of squamous patients, well below the 60%–70% in the general NSCLC population. Median follow-up was 7.1 months. Among 62 efficacy-evaluable patients, ORR was 71.0%, DCR was 95.2%, and the 6-month PFS rate was 70.6%.
Strong and consistent efficacy in squamous NSCLC: ORR was 87.1%, DCR was 96.8%, and the 6-month PFS rate was 86.7%. Comparable benefit was observed regardless of PD-L1 expression, with ORRs of 84.6% in PD-L1-positive and 88.2% in PD-L1-negative patients, and 6-month PFS rates of 84.6% and 87.4%, respectively.
Deep and durable responses in non-squamous NSCLC: Among PD-L1-positive patients, ORR was 81.8%, DCR was 100.0%, and the 6-month PFS rate was 90.0%. Notably, substantial responses were also observed in patients with low PD-L1 expression (TPS 1%–49%).
Favorable safety: Opamtistomig plus chemotherapy demonstrated a manageable safety profile generally consistent with PD-(L)1 antibody-based chemotherapy combinations, with no new safety signals observed.
These findings support the potential of opamtistomig’s differentiated PD-L1/4-1BB dual-target mechanism to provide broad and durable clinical benefit across PD-L1 expression levels, including patient populations that remain underserved by conventional immunotherapy.
As the first PD-L1/4-1BB bispecific antibody to enter NDA review globally, opamtistomig is being developed as a potential next-generation IO 2.0 backbone therapy. It is currently being evaluated in 14 solid tumor indications, with clinical evidence emerging across seven tumor types, including NSCLC, ESCC, EP-NEC, BTC, and platinum-resistant ovarian cancer. Approximately 800 patients with solid tumors have been treated to date, with a favorable overall safety profile.
Executive Commentary
Dr. Charles Cai, Chief Medical Officer of Leads Biolabs, said: "The updated WCLC data are highly encouraging. With longer follow-up, tumor shrinkage continued to deepen and ORR continued to increase, providing further evidence of the durability of opamtistomig’s antitumor activity. Particularly noteworthy is the consistent efficacy observed regardless of PD-L1 expression in squamous NSCLC, together with deep and durable responses in PD-L1-positive non-squamous NSCLC, including patients with low PD-L1 expression.
Despite more than 90% of patients having stage IV disease and many presenting with difficult-to-treat metastatic disease, opamtistomig plus chemotherapy continued to demonstrate encouraging efficacy and PFS outcomes. These findings further support its potential clinical value in first-line NSCLC. We are advancing Phase III development and look forward to bringing this next-generation immunotherapy to more patients."
About NSCLC
According to data from the International Agency for Research on Cancer (IARC) in 2022, there are approximately 2.48 million new cases of lung cancer and approximately 1.82 million lung cancer-related deaths worldwide each year. According to data published by the National Cancer Center of China, there were approximately 1.18 million new lung cancer cases and approximately 743,000 lung cancer-related deaths in China in 2024. NSCLC accounts for approximately 85% of all lung cancer cases. Due to the aggressive nature of NSCLC and the lack of effective early screening methods, approximately 70% of patients with NSCLC in China are diagnosed at an advanced stage.
Patients with NSCLC harboring actionable genetic alterations (AGAs) such as epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK) and ROS proto-oncogene 1 (ROS1) may benefit from corresponding targeted therapies, while patients without AGAsstill rely primarily on immunotherapy in combination with chemotherapy. Further prolonging survival and achieving more durable and deeper responses remain key unmet needs in clinical practice. In squamous NSCLC, AGAs are rare, and patients generally cannot benefit from targeted therapies. Commonly used drugs such as pemetrexed and bevacizumab are also unsuitable for squamous NSCLC due to efficacy or safety concerns, resulting in limited treatment options. Although PD-1/PD-L1 inhibitors in combination with chemotherapy have expanded treatment options for patients with squamous NSCLC, prognosis remains poorer than in non-squamous NSCLC due to differences in biology, clinical features and treatment responses, with a median PFS of only 5 to 8 months and a median overall survival (OS) of 17 to 27 months, highlighting a significant unmet medical need for more effective treatment options.
About Opamtistomig
Opamtistomig (LBL-024) is emerging as a next-generation pan-cancer backbone therapy with potential overall survival (OS) benefit that simultaneously targets PD-L1 and the co-stimulatory receptor 4-1BB. Currently, opamtistomig is being evaluated in 14 indications, including one pivotal single-arm registrational study, one confirmatory Phase III study, and nine proof-of-concept studies, covering major indications such as NSCLC and multiple cold tumors. To date, opamtistomig has demonstrated robust antitumor activity across seven tumor types—extrapulmonary neuroendocrine carcinoma (EP-NEC), non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), biliary tract cancer (BTC), hepatocellular carcinoma (HCC), esophageal squamous cell carcinoma (ESCC), and ovarian cancer (OC)—highlighting its clinical value and broad therapeutic promise.
Developed using Leads Biolabs’ proprietary X-Body bispecific platform, opamtistomig is designed to simultaneously block PD-1/PD-L1 immune suppression and conditionally activate 4-1BB, an agonist pathway, resulting in a potent and synergistic anti-tumor immune response. It has a safety profile comparable to PD-1/PD-L1 inhibitors and demonstrates broader-spectrum anti-cancer potential. Mechanistically, 4-1BB agonism can reactivate exhausted T cells and promote robust T-cell proliferation, offering significant promise for PD-1/PD-L1–resistant or immunologically "cold" tumors and potentially offering durable survival benefits.
Recognizing its clinical potential, opamtistomig received Breakthrough Therapy Designation (BTD) from China’s National Medical Products Administration (NMPA) in October 2024, and Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) in November 2024. Additionally, in January 2026, opamtistomig was granted Fast Track Designation (FTD) by the FDA and ODD by the European Commission, further underscoring its potential to address unmet medical needs in this patient population. In July 2026, its New Drug Application (NDA) was granted priority review designation by the NMPA, followed by NDA acceptance in August 2026, positioning opamtistomig as a potential world’s first approved 4-1BB-targeting antibody, the first approved agonist antibody, and the first approved treatment for EP-NEC.
(Press release, Nanjing Leads Biolabs, SEP 14, 2026, View Source [SID1234670850])