Ogivri (trastuzumab-dkst)

Our study reinforces the existing pivotal data, underscoring the real-world efficacy and safety of biosimilar trastuzumab-dkst in the adjuvant treatment for early HER2-positive breast cancer. The preliminary long-term effectiveness and safety data we present further validate trastuzumab-dkst's role as a cost-saving alternative in oncological care. These findings have important implications for improving patient access to crucial treatments and for the more efficient use of healthcare resources.

Treatment of patients with HER2-positive BC with the trastuzumab biosimilar Ogivri resulted in equivalent symptoms, adverse events, and well-being as found for patients treated with Herceptin as determined by ePRO data. Hence, integration of an ePRO system into research and clinical practice can provide reliable information when investigating the real-world tolerability and outcomes of similar therapeutic compounds.

Methodology: In this prospective observational study, patients with HER2-positive BC were treated with OgivriTM alone +/- Pertuzumab, +/- Chemotherapy and hormone therapy in neo-adjuvant, adjuvant and non-curative settings...Of note, when treatments were compared restricted to the trastuzumab antihormones and trastuzumab- paclitaxel therapies, this reported trend seamed weaker... No difference was reported for symptoms, adverse events, and well-being with respect to the Trastuzumab biosimilar OgivriTM in comparison with HerceptinTM. The integration of ePRO into research and clinical practice provides reliable information when investigating real world tolerability and outcomes of similar therapeutic compounds.

Methods A total of 113 HER2-positive breast cancer patients were enrolled between February 2020 and December 2022 and treated with trastuzumab biosimilars (OGIVRI®, trastuzumab-dkst). Biosimilar trastuzumab demonstrated efficacy in the neoadjuvant setting, while dual blockade with biosimilars resulted in better disease control in the metastatic setting. Further follow-up is necessary to evaluate the efficacy of trastuzumab biosimilars in the adjuvant setting.

P=N/A, N=170, Active, not recruiting, Libbs Farmacêutica LTDA | Recruiting --> Active, not recruiting | Trial completion date: Mar 2024 --> Jul 2028 | Trial primary completion date: Dec 2021 --> Dec 2022

Methodology: In this prospective observational study, patients were treated for HER2-positive BC with Ogivri TM alone +/- Pertuzumab, +/- Chemotherapy in neo-adjuvant, adjuvant and non-curative settings. Our data indicate that no obvious difference was reported for symptoms and adverse events with respect to the Trastuzumab biosimilar Ogivri TM and Herceptin TM . Additionally, integration of ePRO into research and clinical practice provides reliable information when investigating tolerability of similar compounds.

Methods In this 6 week observational study, patients were treated with trastuzumab (Ogivri®) +/- Pertuzumab, +/- Chemotherapy +/- anti-hormones. Conclusions The majority of patients continued the ePRO app use after end of study participation. Only 1 drop out (from 53 pats) was noted in this propsective observational study.

All 59 participants received adjuvant anti-HER2 therapy, that included trastuzumab biosimilar administration trastuzumab biosimilar + pertuzumab (22.0%), and only two patients were receiving reference trastuzumab, which was switched to trastuzumab biosimilar upon entry into the study... The nature and severity of AEs observed to trastuzumab biosimilar were consistent with the known safety profile of trastuzumab. Clinical trial information: NCT03892655. >

Two biosimilars are available at ower institution since 2017 (Hertraz® 440mg Mylan and CanMab ® AbdiBrahim)...Methods A retrospctive study was conducted based on 193 files of stage I-III her2-positive breast cancer treated with neoadjuvant chemotherapy (NACT) including trastuzumab only, since pertuzumab is not available at our level...Conclusions Our study demonstrated the efficacy of trastuzumab biosomilar compared to Referent trastuzumab in the neoadjuvant setting, since the two arms whowed comparable pCR rates, even if more luminal tumors were recorded in the biosimilar arm, considered as resistance factor to neoadjuvant treatment. This is an important result considering different cost of the two options.

These data suggest that biosimilar trastuzumab MYL-1401O has similar effectiveness and cardiac safety to RTZ in patients with HER2-positive EBC or MBC.

Neoadjuvant therapy included the trastuzumab biosimilar administration (25%) and the dual anti-HER2 block (trastuzumab biosimilar + pertuzumab) (68.8%)... The nature and severity of AEs observed were consistent with the known safety profile of trastuzumab.

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 further supports the similarity of trastuzumab-dkst with originator trastuzumab and establishes trastuzumab-dkst as a safe and effective treatment option for patients with HER2-positive MBC. ClinicalTrials.gov NCT02472964; 6/16/2015.

P=N/A, N=170, Recruiting, Libbs Farmacêutica LTDA | Trial primary completion date: Mar 2021 --> Dec 2021

pCR rates were similar for patients treated with trastuzumab-dkst compared to trastuzumab in our real world study of HER2+ neoadjuvant EBC and comparable to pivotal phase 3 trials . For a 65 kg patient, the estimated cost savings of trastuzumab-dkst therapy is $22,000, and approximately $240-300 for a non-anthracycline chemotherapy backbone.

The correlation between ORR and PFS supports the design of first-line metastatic trials assessing biosimilar trastuzumab. Overall, trastuzumab-dkst and trastuzumab were well tolerated with similar efficacy, including ORR and PFS, in combination with a taxane followed by monotherapy.

Biosimilar intravenous trastuzumab-dkst (BIOSIMTras) saves costs versus TrasIV and versus TrasSC in some circumstances... Simulations of administration time and drug+administration costs for one MBC patient over one year of monotherapy and one year of Tras+pertuzumab(Per)+paclitaxel(Pac)... BIOSIMTras monotherapy is cost efficient over TrasIV in all mBC patients and over TrasSC in average and below-average weight patients. BIOSIMTras+Per+Pac is cost efficient over TrasIV and TrasSC in all patients. Savings from conversion to BIOSIMTras can be reallocated—on a budget-neutral basis—to provide expanded access to additional patients or cycles.

The cyclic VHCDR3-derived peptide (Rb9) from RebMab200 antibody, directed to a NaPi2B phosphate-transport protein, displayed anti-metastatic melanoma activity at 50-300 μg intraperitoneally injected in syngeneic mice...Recently, the interaction MIF-CD74 has been associated to PD-L1 expression and IFN-γ, suggesting a target for melanoma treatment. The effects described for Rb9 and the protection against metastatic melanoma may suggest the possibility of a peptide reagent that could be relevant when associated to modern immunotherapeutic procedures.

Pop PK profiles of MYL-1401O vs. Herceptin ® were similar in patients with HER2positive mBC. Model-based exposure measures were similar between treatments.

P1; Not yet recruiting --> Recruiting

P=N/A, N=170, Recruiting, Libbs Farmacêutica LTDA | Trial primary completion date: Mar 2020 --> Mar 2021

P2; N=16; Not yet recruiting; Sponsor: University of Washington

Five trastuzumab biosimilars: MYL-1401O (Ogivri), CT-P6 (Herzuma), SB3 (Ontruzant), PF-05280014 (Trazimera), and ABP980 (Kanjinti), have now been approved by the US Food and Drug Administration (FDA) for use in HER2-positive breast cancers. This review provides an overview of these agents with special consideration of the development and approval process, including available clinical data results for these trastuzumab biosimilars. Adoption in the clinic will depend on the degree of comfort with the overall evidence.

P1; N=24; Not yet recruiting; Sponsor:University of Washington