Evidence map›Paper›PMID 41859632›Full record

ArticleCureus2026

Real-World Evaluation of a Trastuzumab Emtansine Biosimilar (Ujvira®) in Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Breast Cancer.

M V Chandrakanth, Vivek Agarwala, Rupam Manna, Amit Sharma, Minakshi Roy, Anish Dasgupta, Kaustav Mandal, Nibedita Sen, Pritam K Sardar, Aparajita Sadhya and 5 more

Abstract read
In one paragraph

Article in Cureus, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Review
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors.

M V ChandrakanthMedical Oncology, Narayana Superspeciality Hospital, Kolkata, IND.
Vivek AgarwalaMedical Oncology, Narayana Superspeciality Hospital, Kolkata, IND.
Rupam MannaMedical Oncology, Narayana Superspeciality Hospital, Kolkata, IND.
Amit SharmaMedical Oncology, Narayana Superspeciality Hospital, Kolkata, IND.
Minakshi RoyMedical Oncology, Rabindranath Tagore International Institute of Cardiac Sciences, Kolkata, IND.
Anish DasguptaMedical Oncology, Narayana Superspeciality Hospital, Kolkata, IND.
Kaustav MandalMedical Oncology, Rabindranath Tagore International Institute of Cardiac Sciences, Kolkata, IND.
Nibedita SenMedical Oncology, Narayana Superspeciality Hospital, Kolkata, IND.
Pritam K SardarMedical Oncology, Narayana Superspeciality Hospital, Kolkata, IND.
Aparajita SadhyaMedical Oncology, Narayana Superspeciality Hospital, Kolkata, IND.
Moinak BasuMedical Oncology, Narayana Superspeciality Hospital, Kolkata, IND.
Subhabrata KumarMedical Oncology, Rabindranath Tagore International Institute of Cardiac Sciences, Kolkata, IND.
Himadri NayakMedical Oncology, Rabindranath Tagore International Institute of Cardiac Sciences, Kolkata, IND.
Vipulkumar ThummarMedical Affairs, Zydus Lifesciences Ltd, Ahmedabad, IND.
Priya MehtaMedical Affairs, Zydus Lifesciences Ltd, Ahmedabad, IND.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTrastuzumab emtansine (T-DM1) is widely regarded as a standard treatment for human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC), but its cost puts it beyond the reach of many patients in low- and middle-income countries. Ujvira® (ZRC-3256; Zydus Lifesciences, India), a biosimilar version, could offer a more affordable alternative, although real-world experience with it is still limited.

methodsThis retrospective, single-center study evaluated the efficacy and safety of Ujvira® in patients with HER2-positive MBC treated at a tertiary cancer center in India. All patients had prior trastuzumab exposure and received Ujvira® 3.6 mg/kg intravenously every 21 days until progression or unacceptable toxicity. The primary endpoint was progression-free survival (PFS), estimated by the Kaplan-Meier method. Secondary endpoints included objective response rate (ORR), safety (graded per CTCAE v5.0), and exploratory subgroup analyses based on ECOG performance status, hormone receptor expression, comorbidities, and metastatic pattern.

resultsFifty-one patients were included (mean age 58.0 ± 8.4 years; 47 (92.2%) postmenopausal). Median PFS was 6.9 months (95% CI 6.2-9.0) overall, 7.7 months in the second-line setting, and 9.1 months in the third-line setting. The ORR was 35.3%. Treatment was well tolerated; the most common adverse events were thrombocytopenia in 17 patients (33.3%) and anemia in 10 patients (19.6%). Dose reductions occurred in eight patients (15.7%), which did not affect efficacy (PFS 6.8 vs 6.9 months; p = 0.25).

conclusionsIn this real-world Indian cohort, Ujvira® demonstrated efficacy and safety consistent with innovator T-DM1, with preserved outcomes even among heavily pretreated and comorbid patients. These results support Ujvira® as an effective, tolerable, and accessible therapeutic option for HER2-positive MBC in resource-limited settings.

Indexed as

her2-positive breast cancermetastatic breast cancerprogression-free survivalreal-world evidencetrastuzumab emtansine biosimilarujvira®

Identifiers

PMID41859632
PMCPMC12997381

What Socratic holds

Textmetadata
LicenceCC BY
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.