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Association details:
Evidence:
Evidence Level:
Sensitive: B - Late Trials
Title:

Final overall survival analysis of the phase 3 HERITAGE study demonstrates equivalence of trastuzumab-dkst to trastuzumab in HER2-positive metastatic breast cancer

Published date:
06/14/2021
Excerpt:
This is the first phase 3 trial of a trastuzumab biosimilar to report long-term survival data similar to originator trastuzumab in patients with MBC. The comparable long-term OS between the trastuzumab-dkst and originator trastuzumab groups…
DOI:
10.1007/s10549-021-06197-5
Trial ID:
Evidence Level:
Sensitive: B - Late Trials
New
Title:

Biosimilar trastuzumab-dkst monotherapy versus trastuzumab monotherapy after combination therapy: Final overall survival (OS) from the phase III HERITAGE Trial.

Excerpt:
The multicenter, double-blind, randomized, parallel-group, phase 3 Heritage trial (NCT02472964) evaluated efficacy and safety of trastuzumab-dkst (Ogivri), a trastuzumab biosimilar, vs trastuzumab, plus taxane as first-line therapy for patients with HER2+ metastatic breast cancer...Median duration of response was 9.9 and 9.8 months and median OS was 35.0 and 30.2 months for trastuzumab-dkst and trastuzumab, respectively...
DOI:
10.1200/JCO.2019.37.15_suppl.1021
Trial ID:
Evidence Level:
Sensitive: C1 - Off-label
  (Approved for Gastroesophageal Junction Adenocarcinoma)
New
Excerpt:
Ogivri in combination with capecitabine or 5-fluorouracil and cisplatin is indicated for the treatment of adult patients with HER2 positive metastatic adenocarcinoma of the stomach or gastroesophageal junction who have not received prior anti-cancer treatment for their metastatic disease.
Evidence Level:
Sensitive: C3 – Early Trials
Title:

150P - Pathological complete response after neoadjuvant chemotherapy in Her2 positive breast cancer, efficacy of biosimilar compared to Herceptin® (ID 362)

Published date:
05/07/2023
Excerpt:
A retrospctive study was conducted based on 193 files of stage I-III her2-positive breast cancer….Two biosimilars are available at ower institution since 2017 (Hertraz® 440mg Mylan and CanMab ® AbdiBrahim)….Our study demonstrated the efficacy of trastuzumab biosomilar compared to Referent trastuzumab in the neoadjuvant setting, since the two arms showed comparable pCR rates, even if more luminal tumors were recorded in the biosimilar arm, considered as resistance factor to neoadjuvant treatment.
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Trastuzumab-dkst versus trastuzumab: Real-world pCR rates in patients with HER2+ breast cancer treated with neoadjuvant chemotherapy plus trastuzumab from Alberta, Canada.

Published date:
05/19/2021
Excerpt:
Neoadjuvant patients with HER2+ EBC treated with trastuzumab from November 2018 -October 2019 and trastuzumab-dkst from December 2019 - September 2020 were identified….pCR was 35.6% for patients treated with trastuzumab-dkst versus 40.3% with trastuzumab (p = 0.598).
DOI:
10.1200/JCO.2021.39.15_suppl.e12569