Real-World Clinical Outcomes of Ujvira® (Trastuzumab Emtansine Biosimilar) in HER2-Positive Breast Cancer: A Retrospective Observational Study in Indian Patients
Bibliographic record
Abstract
Background: HER2-positive breast cancer is an aggressive subtype requiring targeted therapies. Trastuzumabemtansine has shown efficacy in clinical trials but remains costly, limiting accessibility in low-resource settings. Ujvira®, a biosimilar of T-DM1, offers a more affordable alternative. This study evaluates its real-world efficacy and safety in Indian patients. Methods: This is a retrospective analysis of HER2-positive breast cancer patients treated with Ujvira® between January 2022 and December 2023 at a tertiary care center in India. Primary endpoint was progression-free survival (PFS). Secondary endpoints included overall survival (OS), safety and clinical response per RECIST v1.1. Kaplan-Meier analysis was used for survival estimates; comparisons across lines of therapy were assessed using the log-rank test. Results: The study included 23 patients (median age 51 years, range 35–72), with 74% having an ECOG performance status of 0–1. T-DM1 biosimilar was administered in a palliative setting to 20 patients and as adjuvant therapy to 3 patients. Among the palliative group, 45% had brain metastases at baseline, and treatment was given as second-line in 45%, third-line in 40%, and fourth-line or later in 15% of cases. Overall, 50% achieved a partial response, 35% had stable disease, and 15% showed disease progression. At a median follow-up of 15 months, 30% remained on treatment, 65% had progressed, and one patient was lost to follow-up. The median PFS was 9.6 months, and the median OS was 14 months. In the adjuvant setting, 2 of 3 patients completed 14 cycles, while one progressed with brain metastases after 9 cycles. The most common adverse events were thrombocytopenia, anemia, and transaminitis, with grade 3 events occurring in 26% and grade 4 events in 4% of patients. Conclusion: Ujvira® showed efficacy comparable to innovator T-DM1 in terms of PFS, supporting its role in HER2-positive breast cancer management. However, shorter OS may reflect high brain metastases rates and limited access to post-progression therapies. The study’s retrospective design, small sample size, and selection bias limit generalizability. Larger prospective studies are needed to validate findings.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.004 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.001 | 0.002 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.002 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".