Roche Tam-Peli SCLC trial results announced on 13 September 2026 mark a significant step forward for patients with relapsed small-cell lung cancer. The Basel-based pharmaceutical company Roche (SIX: RO, ROP; OTCQX: RHHBY) confirmed that its collaborator, MediLink Therapeutics, has released interim results from the randomised, open-label phase III TAISHAN-302 trial. The study compared Tam-Peli, known scientifically as tambotatug pelitecan or YL201, against the chemotherapy topotecan in Chinese patients with relapsed small-cell lung cancer (SCLC) who had progressed after one prior line of platinum-based chemotherapy, with or without a PD-L1 inhibitor.
The Roche Tam-Peli SCLC trial, TAISHAN-302, enrolled 451 patients across 85 study sites in China, with 225 patients randomised to Tam-Peli and 226 to topotecan. The trial met its primary endpoint of overall survival (OS), with Tam-Peli reducing the risk of death by 54% compared with topotecan. Median OS reached 13.3 months for patients receiving Tam-Peli versus 9.4 months for those receiving topotecan, a difference that was both statistically significant and clinically meaningful, with a stratified hazard ratio of 0.46 (95% CI: 0.35-0.62) and a p-value below 0.0001.
Beyond the primary endpoint, the Roche Tam-Peli SCLC dataset showed strong results across secondary measures. Progression-free survival (PFS) extended to a median of 7.4 months with Tam-Peli compared with 2.8 months for topotecan, corresponding to a 71% reduction in the risk of disease progression (HR 0.29; 95% CI: 0.23-0.37; p<0.0001). The confirmed objective response rate (ORR) also favoured Tam-Peli by a wide margin, at 59.1% versus 9.7% for topotecan, again reaching high statistical significance.
Roche Tam-Peli SCLC Trial Meets Primary Endpoint With Statistically Significant Survival Benefit
The Roche Tam-Peli SCLC findings from TAISHAN-302 are being presented as a Late-Breaking Abstract during a Presidential Presentation at the International Association for the Study of Lung Cancer (IASLC) 2026 World Conference on Lung Cancer in Seoul, with simultaneous publication in The New England Journal of Medicine. Separately, the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) for Tam-Peli for filing, moving the therapy a step closer to potential approval in China.
Commenting on the Roche Tam-Peli SCLC results, Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development, said the second positive phase III trial for Tam-Peli reinforces confidence in its potential to improve cancer outcomes. He noted the data demonstrate clinically meaningful improvements in survival and response rates in an aggressive, hard-to-treat disease, and that they support plans to move quickly into global phase III studies.
Consistent Roche Tam-Peli SCLC benefits were observed across prespecified patient subgroups, including age, chemotherapy-free interval (defined as less than 90 days versus 90 days or more), and baseline liver or brain metastatic status. Among patients with baseline brain metastases specifically, Tam-Peli extended median intracranial PFS to 6.1 months versus 4.2 months for topotecan (unstratified HR 0.43; 95% CI: 0.27-0.68) and achieved a substantially higher intracranial response rate of 32.4% compared with 2.9% for topotecan, a subgroup result that is particularly relevant given how frequently SCLC spreads to the brain.
Roche Tam-Peli SCLC Safety Profile Shows Fewer Severe Adverse Events Than Topotecan
Alongside efficacy, the Roche Tam-Peli SCLC safety data compared favourably with the established chemotherapy comparator. Grade 3 or higher treatment-related adverse events (TRAEs) occurred in 46.4% of patients receiving Tam-Peli, compared with 74.7% of patients receiving topotecan. Serious TRAEs were likewise less frequent with Tam-Peli, at 25.9% versus 36.4% for topotecan.
One safety signal warranting monitoring in the Roche Tam-Peli SCLC dataset is interstitial lung disease (ILD) and pneumonitis, a known class effect for antibody-drug conjugates. Treatment-emergent ILD or pneumonitis of any grade occurred in 4.9% of Tam-Peli patients compared with 1.4% of topotecan patients. Grade 3 events were low and balanced between arms, at 0.9% in each group, and no Grade 4 or Grade 5 ILD/pneumonitis events were reported in either arm. Overall, the safety profile supports a favourable benefit-risk assessment for Tam-Peli relative to topotecan in this relapsed SCLC population.
Roche Tam-Peli SCLC Mechanism Leverages MediLink’s TMALIN Platform for Targeted Delivery
Tam-Peli is an investigational antibody-drug conjugate (ADC) that targets B7-H3, a protein that is broadly expressed across solid tumours, including on tumour cells and within the surrounding microenvironment, while remaining minimally expressed in healthy tissue. This expression pattern is intended to allow the therapy to selectively engage cancer cells while limiting exposure to normal tissue, a design rationale that underpins the Roche Tam-Peli SCLC efficacy signal described above.
The molecule is built on MediLink Therapeutics’ proprietary TMALIN® (Tumour Microenvironment-Activatable Linker) platform. Tam-Peli links a B7-H3-specific monoclonal antibody to a novel topoisomerase 1 inhibitor payload, carried at a drug-to-antibody ratio of 8. The design combines a stable, hydrophilic linker with a dual-release mechanism, intended to deliver the cytotoxic payload both inside tumour cells and extracellularly within the tumour microenvironment. According to Roche and MediLink, this dual-release approach is designed to maximise antitumour activity while minimising off-target toxicity, a balance that the Roche Tam-Peli SCLC safety results above appear to reflect against topotecan in TAISHAN-302.
Under the terms of a collaboration and exclusive licensing agreement signed in January 2026, Roche holds development, manufacturing, and commercialisation rights for Tam-Peli worldwide, outside of mainland China, Hong Kong, and Macau, where MediLink retains rights. Roche has said it is advancing clinical development of Tam-Peli across multiple solid tumour types within its licensed territories and plans to rapidly initiate global phase III trials for the Roche Tam-Peli SCLC programme and other indications, building on the China-based TAISHAN programme.
Roche Tam-Peli SCLC Regulatory Path Advances With Breakthrough Therapy Designations and NDA Filing
The Roche Tam-Peli SCLC readout from TAISHAN-302 is the second positive phase III result for Tam-Peli overall, following the earlier positive phase III TAISHAN-301 trial in nasopharyngeal carcinoma. Tam-Peli has already received Breakthrough Therapy Designation from both the U.S. Food and Drug Administration (FDA) and China’s CDE specifically for relapsed small-cell lung cancer. Beyond SCLC, the molecule holds two FDA Orphan Drug Designations and three China CDE Breakthrough Therapy Designations across additional tumour types, including nasopharyngeal carcinoma, esophageal squamous cell carcinoma, and pancreatic cancer.
The Roche Tam-Peli SCLC programme arrives against a backdrop of substantial unmet medical need. Lung cancer remains the leading cause of cancer-related death worldwide, claiming an estimated 1.8 million lives each year and surpassing the combined mortality of breast, prostate, and stomach cancers. Small-cell lung cancer accounts for roughly 15% of all lung cancer diagnoses and is considered one of the most aggressive forms of the disease, progressing rapidly regardless of the stage at diagnosis. Despite advances in first-line treatment, SCLC frequently relapses, and outcomes for patients with recurrent disease have historically remained poor, underscoring the need for more effective second-line options such as Tam-Peli.
Roche frames the Roche Tam-Peli SCLC data as an extension of more than two decades of work in lung cancer, a portfolio that already includes approved medicines Alecensa (alectinib), Tecentriq (atezolizumab), and Rozlytrek (entrectinib). The company’s pipeline additionally spans investigational treatments across small-cell lung cancer, non-small cell lung cancer with actionable genomic alterations, and non-small cell lung cancer without such alterations. With the NDA now accepted for filing in China and global phase III trials planned, Tam-Peli’s development trajectory will be closely watched by investors and oncologists tracking the broader B7-H3-targeted ADC treatment landscape.
Key efficacy results from the phase III TAISHAN-302 trial
| Primary and key secondary endpoints | Tam-Peli (n=225) | Topotecan (n=226) | Hazard Ratio (95% CI) | p-value |
|---|---|---|---|---|
| Median OS in months | 13.3 | 9.4 | HR 0.46 (0.35–0.62) | p < 0.0001 |
| Median PFS in months | 7.4 | 2.8 | HR 0.29 (0.23–0.37) | p < 0.0001 |
| Confirmed Objective Response Rate (%) | 59.1 | 9.7 | Not disclosed | p < 0.0001 |
Intracranial subgroup outcomes (patients with baseline brain metastases)
| Endpoint | Tam-Peli | Topotecan | Hazard Ratio (95% CI) |
|---|---|---|---|
| Median intracranial PFS (months) | 6.1 | 4.2 | HR 0.43 (0.27–0.68) |
| Intracranial response rate (%) | 32.4 | 2.9 | Not disclosed |
Safety summary from TAISHAN-302
| Safety measure | Tam-Peli | Topotecan |
|---|---|---|
| Grade ≥3 treatment-related adverse events | 46.4% | 74.7% |
| Serious treatment-related adverse events | 25.9% | 36.4% |
| ILD/pneumonitis, any grade | 4.9% | 1.4% |
| ILD/pneumonitis, Grade 3 | 0.9% | 0.9% |
| ILD/pneumonitis, Grade 4/5 | 0 | 0 |
Trial and regulatory profile
| Attribute | Detail |
|---|---|
| Trial identifier | NCT06612151 |
| Trial name | TAISHAN-302 |
| Design | Randomised, open-label, phase III |
| Enrollment | 451 patients, 85 sites in China |
| Comparator | Topotecan |
| Dosing | Tam-Peli 2.0 mg/kg IV, day 1 of each 21-day cycle, max dose 200 mg |
| Related prior trial | TAISHAN-301 (NCT06629597), nasopharyngeal carcinoma, positive phase III |
| U.S. designation | FDA Breakthrough Therapy Designation, relapsed SCLC |
| China designation | CDE Breakthrough Therapy Designation, relapsed SCLC |
| Regulatory filing | China NMPA CDE has accepted NDA for filing |
| Licensing agreement | Roche and MediLink Therapeutics, effective January 2026, ex-China/Hong Kong/Macau |
