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MSD launches ONTRUZANT®▼ (biosimilar trastuzumab), a biosimilar of intravenous HERCEPTIN®, which is the first breast cancer biosimilar in the UK

MSD
Posted on: 07 Mar 18

MSD launches ONTRUZANT®â–¼ (biosimilar trastuzumab), a biosimilar of intravenous HERCEPTIN®, which is the first breast cancer biosimilar in the UK[1]

 

 

Hoddesdon, [8th March 2018] – MSD today announced the launch of ONTRUZANT®â–¼, (trastuzumab), a biosimilar referencing HERCEPTIN®* (trastuzumab/TRZ), for the treatment of early breast cancer, metastatic breast cancer and metastatic gastric cancer. This was the first trastuzumab biosimilar to receive regulatory approval in Europe and is the first to launch in the UK.1

 

Biosimilar trastuzumab represents the first product approved in the UK under a global biosimilars development and commercialisation agreement between MSD and Samsung Bioepis Co., Ltd.

The European Medicines Agency (EMA) requires biosimilars to show they are highly similar to the reference medicine in terms of structure, biological activity and efficacy, safety and immunogenicity profile.[2] ONTRUZANT (trastuzumab biosimilar (SB3)) is a monoclonal antibody and has been shown to have similar safety and efficacy as its reference product HERCEPTIN (TRZ) in early breast cancer, with breast pathologic complete response rates (bpCR) being 51.7% and 42.0% with SB3 and TRZ respectively. The adjusted ratio of bpCR was 1.259 (95%CI, 1.085 to 1.460), which was within the predefined equivalence margins. The adjusted difference was 10.70% (95% CI, 4.13% to 17.26%), with the lower limit contained within and the upper limit outside the equivalence margin. The overall response rates were 96.3% and 91.2% with SB3 and TRZ. [3]

Dr Mark Verrill, Head of the Department of Medical Oncology at the Newcastle upon Tyne Hospitals NHS Foundation Trust, and the deputy lead clinician for breast cancer in the North of England Cancer Network said, “This is good news for so many cancer patients and the NHS. The launch of biosimilar trastuzumab provides a high-quality treatment alternative for patients, while offering significant potential savings for the NHS. The biggest category of medicines in oncology is monoclonal antibodies and the introduction of biosimilars such as trastuzumab could provide a substantial cost saving.”

 

Denise Blake, Senior Lead Clinical Pharmacist at Newcastle Hospitals, explains, “The introduction of biosimilar trastuzumab provides an opportunity for the NHS to realise substantial financial savings without compromising patient care. Close collaboration between oncologists, pharmacists and nursing staff is required to ensure a seamless introduction into routine clinical practice.”

 

“As a company committed to inventing new treatment options for both common and neglected types of cancer, MSD is also pleased to be offering the NHS a biosimilar medicine in an established area of care. Biosimilar trastuzumab marks a significant milestone for both MSD and the oncology community, providing the UK’s first biosimilar trastuzumab, based on our collaboration with Samsung Bioepis,” explains Louise Houson, UK Managing Director, MSD.

 

Regulatory approval was based on a phase III study that compared SB3 with reference TRZ in patients with human epidermal growth factor receptor HER-2 positive early breast cancer in the neoadjuvant setting.

 

The study showed the total pathologic complete response rates were 45.8% and 35.8% and the overall response rates were 96.3% and 91.2% with SB3 and TRZ, respectively. Eight hundred patients were included in the per-protocol set (SB3, n = 402; TRZ, n = 398). The bpCR rates were 51.7% and 42.0% with SB3 and TRZ, respectively. The adjusted ratio of bpCR was 1.259 (95%CI, 1.085 to 1.460), which was within the predefined equivalence margins. The adjusted difference was 10.70% (95% CI, 4.13% to 17.26%), with the lower limit contained within pre-specified equivalence margins and the upper limit of the confidence interval slightly exceeding the pre-specified equivalence margins (-13%, 13%).

 

Overall, 96.6% and 95.2% of patients experienced one or more adverse event, 10.5% and 10.7% had a serious adverse event, and 0.7% and 0.0% had antidrug antibodies (up to cycle 9) with SB3 and TRZ, respectively.3

 

* HERCEPTIN® is a registered trademark of Genentech Inc.

 

-ENDS-

 

MSD is a trade name of Merck & Co., Inc., with headquarters in Kenilworth, N.J., U.S.A.

 

For further information, please contact:

Susan Collett (MSD)

01992 455471

Susan.collett@merck.com

Reshma Parmar (Red Health)

020 7025 6588

reshma.parmar@redconsultancy.com

 

Notes to editors:

 

About biosimilar trastuzumab (ONTRUZANT)

Biosimilar trastuzumab, a monoclonal antibody, is the first biosimilar of HERCEPTIN (trastuzumab/TRZ) to launch, treating both HER-2 positive early and metastatic breast cancer, as well as metastatic gastric cancer.1 For prescribing information please refer to the Summary of Product Characteristics, online at https://www.medicines.org.uk/emc/product/9047.

 

Biosimilar trastuzumab is highly similar to its reference product HERCEPTIN, which was authorised in the EU on 28 August 2000.[4]

 

Data shows that biosimilar trastuzumab (SB3) has comparable quality, safety and efficacy to HERCEPTIN (trastuzumab/TRZ). SB3 has been shown to have similar safety and efficacy as TRZ in early breast cancer with overall response rates being 96.3% and 91.2% in SB3 and TRZ and the breast pathologic complete response rate [bpCR] was 51.7% for SB3 vs 42.0% for TRZ.3

 

The EMA considers that if a biosimilar is highly similar to a reference medicine and has comparable safety and efficacy in one therapeutic indication, safety and efficacy data can be extrapolated to other indications.2

 

About Breast and Gastric Cancer

 

Breast cancer is the most common cancer in the UK.5 Breast cancer mainly affects women but men can also get it, although this is rare.5 Most women diagnosed with breast cancer are over 50, but younger women can also get breast cancer.[5] About one in eight women are diagnosed with breast cancer during their lifetime.6 There's a good chance of recovery if it's detected in its early stages.6 Survival rates of 10-years or more have doubled in the last 40 years due to improved diagnosis, treatment and care.[6]

 

Stomach cancer, or gastric cancer, is a fairly uncommon type of cancer. Around 7,000 people are diagnosed with it each year in the UK. As the early symptoms of stomach cancer are similar to those of many other conditions, the cancer is often advanced by the time it's diagnosed. It's therefore important to get any possible symptoms of stomach cancer checked by a GP as soon as possible.[7]

 

Phase III data3

The phase III study compared SB3 with reference TRZ in patients with human epidermal growth factor receptor 2–positive (HER2-positive) early breast cancer in the neoadjuvant setting (ClinicalTrials.gov identifier: NCT02149524).

 

Patients were randomly assigned to receive neoadjuvant SB3 or TRZ for eight cycles concurrently with chemotherapy (four cycles of docetaxel followed by four cycles of fluorouracil, epirubicin, and cyclophosphamide) followed by surgery, and then 10 cycles of adjuvant SB3 or TRZ.

 

The primary objective was comparison of breast pathologic complete response (bpCR) rate in the per-protocol set (defined as all patients who completed eight cycles of neoadjuvant therapy and surgery without prespecified, major protocol deviations); equivalence was declared if the 95% CI of the ratio was within 0.785 to 1.546 or the 95% CI of the difference was within ±13%. Secondary end points included comparisons of total pathologic complete response rate, overall response rate, event-free survival, overall survival, safety, pharmacokinetics, and immunogenicity.

 

Eight hundred patients were included in the per-protocol set (SB3, n = 402; TRZ, n = 398). The bpCR rates were 51.7% and 42.0% with SB3 and TRZ, respectively. The adjusted ratio of bpCR was 1.259 (95%CI, 1.085 to 1.460), which was within the predefined equivalence margins. The adjusted difference was 10.70% (95% CI, 4.13% to 17.26%), with the lower limit contained within the equivalence margin and the upper limit outside the equivalence margin. The total pathologic complete response rates were 45.8% and 35.8% and the overall response rates were 96.3% and 91.2% with SB3 and TRZ, respectively.

 

Overall, 96.6% and 95.2% of patients experienced one or more adverse event, 10.5% and 10.7% had a serious adverse event, and 0.7% and 0.0% had antidrug antibodies (up to cycle 9) with SB3 and TRZ, respectively.

 

Equivalence for efficacy was demonstrated between SB3 and TRZ on the basis of the ratio of bpCR rates. Safety and immunogenicity were comparable.

 

Safety3

During the neoadjuvant period, Treatment-emergent adverse events (TEAEs) were reported in 96.6% of patients (422 of 437 patients) in the SB3 group and 95.2% of patients (417 of 438 patients) in the TRZ group. The most common TEAEs were neutropenia, alopecia, nausea, and leukopenia. TEAEs resulted in the death of four patients (one suicide in the SB3 group and one death each as a result of myocardial infarction, sudden death, and pulmonary embolism in the TRZ (group); none of these events were considered to be related to study drug. The incidence of TEAEs of special interest was similar between the arms. Two patients in the SB3 group presented with CHF. The first patient, with a history of hypertension and diabetes, had the event reported at cycle 5 and recovered from the event 11 days later. The second patient had the event reported at cycle 6 and recovered 11 days later.

 

About MSD

At MSD, we believe the most important thing we make is a difference. We operate in more than 140 countries and through our prescription medicines, vaccines, biologic therapies, and animal health products we work with customers to bring innovative healthcare solutions to those who need them the most. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programmes and partnerships.

 

MSD believes that appropriate use of a biosimilar in some clinical settings has the potential to offer an alternative to existing biologic therapies which can address the needs of the NHS healthcare system.  MSD’s vision is to help improve human health by increasing access to important life-changing medicines.

 

For more information visit www.msd-uk.com. The company is known as Merck & Co., Inc., Kenilworth, NJ, USA in the United States and Canada. Everywhere else, we are known as MSD.

 

MSD is first and foremost a research-intensive, innovative biopharmaceuticals company. We believe that strong intellectual property protections are an important incentive for continued investment in this innovation.

 

MSD’s advocacy position on originator and biosimilar biologics is built upon a foundational objective of seeking to improve patient health outcomes while maintaining patient safety. All MSD policies associated with originator biologics, biosimilars, or any other drug regulation, are motivated first and foremost by our focus on the patient.

 

We are confident that our collaboration with Samsung Bioepis will result in the availability of high quality biosimilars that can improve patient access to these lifesaving biological medicines, while respecting the intellectual property rights of the originator.

 

Forward-Looking Statement

This news release of MSD (the “company”) includes “forward-looking statements” within the meaning of the safe harbour provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialise, actual results may differ materially from those set forth in the forward-looking statements.

 

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s 2017 Annual Report on Form 10-K and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov)

 

###

References

 

[1]  EMC. (2018). Ontruzant 150 mg powder for concentrate for solution for infusion. [online] Available at: https://www.medicines.org.uk/emc/product/9047 [Accessed 7 Mar. 2018].

[2] EMA. Biosimilar in the EU. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Leaflet/2017/05/WC500226648.pdf. [Accessed 22 Feb. 2018].

[3] Pivot, X., Bondarenko, I., Nowecki, Z. et al. (2018). Phase III, Randomized, Double-Blind Study Comparing the Efficacy, Safety, and Immunogenicity of SB3 (Trastuzumab Biosimilar) and Reference Trastuzumab in Patients Treated With Neoadjuvant Therapy for Human Epidermal Growth Factor Receptor 2–Positive Early Breast Cancer. Published at JCO.org on January 28, 2018.

[4] EPAR. HERCEPTIN. [online] Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Summary_for_the_public/human/000278/WC500049819.pdf [Accessed 22 Feb. 2018].

[5]  NHS. Breast cancer in women. [online] Available at: https://www.nhs.uk/conditions/breast-cancer/ [Accessed 15 Feb. 2018].

[6] Cancer Research UK. (2018). Breast cancer survival statistics. [online] Available at: http://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/breast-cancer/survival [Accessed 15 Feb. 2018].

[7] nhs.uk. (2018). Stomach cancer. [online] Available at: https://www.nhs.uk/conditions/stomach-cancer/ [Accessed 15 Feb. 2018].

Editor's Details

Tamara Ghanem
Red
tamara.ghanem@redconsultancy.com

Last updated on: 07/03/2018

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