A recent report from GLMS SEC highlights that substantial opportunities for advancement remain in the first-line treatment of advanced lung cancer. This is due to limited survival benefits for many patients following therapy and the potential for greater adoption of PD-1 monoclonal antibody-based combination therapies over alternatives like chemotherapy. Global pharmaceutical companies are strategically developing treatments based on concepts such as PD-1 monoclonal antibodies combined with Antibody-Drug Conjugates (ADCs) and PD-1 bispecific antibodies.
Within the PD-1 monoclonal antibody plus ADC approach, SKB BIO (06990) and its partner Merck have positioned their sac-TMT candidate with a broad potential indication coverage and a high probability of success, positioning it favorably to lead in this therapeutic pathway. Furthermore, Merck retains a strategic backup option involving a PD-1 bispecific antibody combined with sac-TMT. The firm advises close attention to the global development progress of SKB BIO's sac-TMT program.
Key Perspectives from GLMS SEC
Pembrolizumab, known as Keytruda, achieved global sales exceeding $30 billion in 2025, solidifying its status as a leading oncology drug. Initially approved for first-line lung cancer in 2016, its approved patient population was expanded through four subsequent approvals by April 2019. Overall, PD-1 monoclonal antibodies have secured a dominant position in the first-line lung cancer market. Real-world U.S. treatment data from 2022 indicates that therapies containing PD-1 monoclonal antibodies are used in approximately 76% of all first-line lung cancer patients. However, efficacy and market penetration vary across different patient subgroups, particularly among those with low PD-L1 expression and squamous cell carcinoma, indicating room for improvement.
Closing Window for New Phase III Trials of PD-1 + ADC Combinations; SKB BIO and Merck Have Secured Their Position
Globally, companies including AstraZeneca, Merck, Gilead, and Pfizer initiated global Phase III studies for ADC plus PD-1 monoclonal antibody combinations in first-line lung cancer between 2022 and 2025, primarily targeting Trop2. Considering the potential cross-resistance mechanisms associated with existing ADC payloads and the expected data readout from AstraZeneca's AVANZAR study in the second half of 2026, GLMS SEC suggests the window for initiating new global Phase III studies for ADC+PD-1 combinations may be closing, potentially leading to consolidation in this specific treatment pathway.
sac-TMT Poised to Lead Within the ADC + PD-1 Treatment Landscape
SKB BIO presented data from the Optitrop-Lung05 study at the 2026 ASCO conference. The data showed that sac-TMT combined with pembrolizumab for first-line treatment of advanced NSCLC significantly improved Progression-Free Survival (PFS) compared to pembrolizumab monotherapy. The median PFS for the overall population was not reached versus 5.7 months, with a Hazard Ratio (HR) of 0.35. The HR was 0.28 for the non-squamous subgroup and 0.44 for the squamous subgroup. Overall Survival (OS) also showed a favorable trend with an HR of 0.55. Current data suggests potential safety concerns with Dato-DXd, and Gilead's Trodelvy failed its Phase III study in first-line lung cancer. Consequently, sac-TMT has the potential to emerge as a leading Trop2 ADC candidate in lung cancer and take a front-running position in combination therapy with PD-1 monoclonal antibodies.
Associated Risks
The report outlines several risks, including the potential for research and development failure, commercial sales performance falling short of expectations, slower-than-anticipated industry growth, and uncertainties in key assumptions due to technological evolution.
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