SABCS Posters Evaluate Real-World Outcomes Associated With Ogivri

Two Taiwanese posters from the San Antonio Breast Cancer Symposium (SABCS) 2023 annual meeting evaluated the real-world implications of using trastuzumab biosimilars, particularly Ogivri (trastuzumab-dkst) in patients with HER2-postive breast cancer.

The first study aimed to assess the utilization, efficacy, and safety of trastuzumab biosimilars, specifically Ogivri, in the treatment of patients with HER2-positive breast cancer at Kaohsiung Veterans General Hospital in Kaohsiung City, Taiwan. For reference, Ogivri has been on the US market since December 2019.

The research included 113 patients with HER2-positive breast cancer treated with trastuzumab biosimilars between February 2020 and December 2022. The patient groups comprised those receiving neoadjuvant, adjuvant, and metastatic treatment. The study reported positive clinical outcomes, with a 40.90% pathological complete response rate in the neoadjuvant group, a 57.14% objective response rate, and a 90.47% clinical benefit rate in the metastatic group.

Notably, the metastatic group exhibited better disease control (62.96% objective response rate) with dual blockade using biosimilars. Importantly, no adverse events related to cardiac toxicity were reported in any group.

The conclusions drawn from the real-world experience suggested that trastuzumab biosimilars are a safe and cost-effective alternative to the reference trastuzumab for treating HER2-positive breast cancer. The biosimilar was efficacious in the neoadjuvant setting, and the use of dual blockade in the metastatic setting showed improved disease control. However, the study recommended longer follow-up for the adjuvant group to comprehensively evaluate the efficacy of trastuzumab biosimilars in that setting.

The second poster focused patient-reported outcomes, adverse effect profiles, and quality-of-life measurements using an electronic reporting system after using Ogivri. The medidux app was employed to dynamically record standardized and structured electronic patient reported outcomes (ePROs) during Ogivri treatment and compare them with historical data from patients treated with the reference product (Herceptin) in prior studies.

The prospective observational study included 52 women with HER2-positive breast cancer treated with Ogivri in various settings. Patients used the medidux app over a 6-week observational period to record symptoms, well-being, cognitive capabilities, and vital parameters. A comparative analysis was conducted with historical data from 38 patients treated with Herceptin in similar therapeutic settings, involving 5217 ePROs and more than 1400 reports of well-being.

Results indicated that, among the 92 symptoms available, 84 were recorded, with an average of more than 2 symptoms per day, totaling 10,532 individual patient entries. Common symptoms reported in both groups included fatigue, taste disorder, nausea, diarrhea, and others.

Overall, symptoms associated with Ogivri were reported with a similar incidence and distribution compared with Herceptin, with slightly lower scores. The majority of patients in the Ogivri cohort experienced mild and grade 1 toxicities, indicating a favorable tolerability profile.

Notably, no significant differences were reported for symptoms, adverse events, and well-being between Ogivri and Herceptin, suggesting that the trastuzumab biosimilar Ogivri is comparable in terms of tolerability and outcomes in real-world clinical settings. The study underscored the value of integrating ePROs into research and clinical practice to obtain reliable information on the tolerability and outcomes of similar therapeutic compounds in real-world scenarios.

References

1. Lo Y-H, Tzeng Y-D. Real-world evidence of trastuzumab biosimilars in HER2-positive breast cancer: Evaluating utilization, efficacy, and safety in Taiwan. Presented at: SABCS 2023; December 5-9, 2023; San Antonio, TX. Poster PO1-17-03.

2. Trojan A, Roth S, Zenhäusern R, et al. HER2-directed biosimilar Ogivri in the treatment of breast cancer: real world reporting of symptoms and wellbeing using electronic patient reported outcome (ePRO). Presented at: SABCS 2023; December 5-9, 2023; San Antonio, TX. Poster PO1-17-04.