Healthcare Industry News:  NSCLC 

Biopharmaceuticals Oncology Regulatory

 News Release - September 5, 2016

Eisai Bewildered as German Institute for Quality and Efficiency in Health Care (IQWIG) Fails to Recognise Additional Benefit of Halaven(R) (eribulin) in the Treatment of Advanced Liposarcoma

Assessment ignores unprecedented overall survival benefit for eribulin in advanced liposarcoma[1]

HATFIELD, England, September 4, 2016 -- (Healthcare Sales & Marketing Network) -- The German Institute for Quality and Efficiency in Health Care (IQWiG) has published a report which suggests that on formal or methodological grounds, respectively, no additional benefit has been proven for Halaven® (eribulin) versus established comparator therapies - as defined by the Federal Joint Committee (G-BA) - for the treatment of unresectable advanced or metastatic liposarcomas.[2] The dossier submitted by Eisai for the assessment included a direct comparison to dacarbazine (based on Eisai's phase III study 309) as well as an indirect comparison to trabectedin. With its suggestion, IQWiG ignores pivotal phase III data which demonstrated clearly that eribulin is the first and only single agent therapy to show a statistically significant overall survival advantage in advanced liposarcoma.[1]

"Eribulin has demonstrated a statistically significant survival advantage over dacarbazine in the treatment of advanced liposarcoma. This is a very rare and difficult to treat type of soft tissue sarcoma for which treatment options are few and existing therapies are associated with only limited efficacy. The clinical importance of this unprecedented survival benefit cannot be overstated for people who live with advanced liposarcoma and urgently need new and effective treatment options, such as eribulin," comments Dr. Helga Schmitz, Medical Director, Eisai GmbH.

The final decision on the additional benefit of eribulin lies with the G-BA and is expected for the end of December 2016, following due and balanced consideration of all relevant aspects of the IQWiG report, written statements and an oral hearing of experts and patient representatives.

In study 309, the pivotal phase III trial on which the indication approval was based, eribulin was the first and only single agent therapy to demonstrate a significant survival advantage in advanced liposarcoma.[1] Results from Study 309 showed that patients treated with eribulin compared to those treated with dacarbazine, a longstanding established and internationally accepted treatment option, benefitted from a median 7.2 month increase in overall survival for the pre-specified subgroup of patients with unresectable advanced or metastatic liposarcoma (15.6 months versus 8.4 months, HR = 0.511; 95% CI 0.346-0.753; P=0.0006).[1] [3] In this study, the most common adverse events observed in the eribulin arm were neutropenia, fatigue, nausea, alopecia and constipation, which is consistent with the known safety profile of eribulin. The most common adverse events observed in the dacarbazine arm were nausea, fatigue, anemia, thrombocytopenia and constipation.[1]

Soft tissue sarcomas develop from cells in essential tissues within the body such as fat, muscle, nerves, fibrous tissues and blood.[4],[5] Liposarcomas (adipocytic sarcomas) originate in fat cells and can occur anywhere in the body.[5]Comprising approximately 17% of all cases of soft tissue sarcomas, liposarcomas represent the most common subtype.[6],[7] Sarcomas represent about 1% of all cancers diagnosed in Europe.[5] Approximately 3,000 people in Germany are diagnosed with soft tissue sarcomas each year.[8]

"Eisai cannot understand the suggestion of the IQWiG that no additional benefit has been proven for eribulin, despite compelling phase III data which show an overall survival benefit. We are hopeful that, notwithstanding the report by IQWIG, the G-BA will take a more informed view," comments Dr. Patrik Höller, Director Oncology Business Group, Eisai GmbH.

In May 2016, the European Commission approved a variation to the terms of the Marketing Authorisation (MA) of eribulin for the treatment of adult patients with unresectable liposarcomas who have received prior anthracycline containing therapy (unless unsuitable) for advanced or metastatic disease.

Eribulin is also licensed in Europe for the treatment of patients with locally advanced or metastatic breast cancer who have progressed after at least one chemotherapeutic regimen for advanced disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting, unless patients were not suitable for these treatments.[9]

Eisai is dedicated to the discovery, development and production of innovative oncology therapies that can make a difference and impact the lives of patients and their families. This passion for people is part of Eisai's human health care (hhc) mission, which strives to better understand the needs of patients and their families to increase the benefits health care provides.

Notes to Editors

Halaven® (eribulin)

Eribulin is the first in the halichondrin class of microtubule dynamics inhibitors with a novel mechanism of action. Structurally eribulin is a simplified and synthetically produced version of halichondrin B, a natural product isolated from the marine sponge Halichondria okadai. Eribulin is believed to work by inhibiting the growth phase of microtubule dynamics which prevents cell division.

About Soft Tissue Sarcomas

Soft tissue sarcoma is a collective term for a diverse group of malignant tumours.

Unlike other cancers such as non-small cell lung cancer (NSCLC), soft tissue sarcomas are mostly diagnosed with localised disease, and many are amenable to complete surgical removal, yet relapse rates can be as high as 50 percent.[10]Outcomes for patients with advanced disease are poor, with median survival around one year or less. Due to the rarity of these tumours, evidence for prognostic factors is weak and not well understood.[11]

Global Phase III Clinical Study 309[1]

The primary endpoint of the study was to compare overall survival between patients treated with eribulin mesilate (1.4 mg/m² intravenously on days 1 and 8) and those treated with dacarbazine (850 mg/m², 1000 mg/m², or 1200 mg/m² [dose dependent on centre and clinician] intravenously on day 1). The additional endpoints included progression free survival and quality of life.

Patients were aged =18 years with advanced high/intermediate grade leiomyosarcoma or dedifferentiated, myxoid, round cell or pleomorphic variants of adipocytic sarcoma incurable by surgery and/or radiotherapy were enrolled. Patients had ECOG status =2 and had received =2 standard systemic treatment regimens including an anthracycline. Patients were randomized 1:1 and received eribulin mesilate (1.4 mg/m2, IV on D1 and D8) or dacarbazine (850-1200 mg/m2, IV on D1) every 21 days until disease progression.

Overall, 452 patients (67% female; 79% <65 years) were randomized (228 eribulin; 224 dacarbazine). Median OS for eribulin and dacarbazine was 13.5 and 11.5 months, respectively (HR=0.768, 95% CI 0.618-0.954; P=0.017). PFS was 2.6 months in both arms (HR=0.877, 95% CI 0.710-1.085; P=0.229). PFS rate at week 12 was 33% and 29% for eribulin and dacarbazine, respectively. Eribulin had a toxicity profile consistent with prior experience, with no unexpected or new safety findings. In this study, the most common adverse events observed in the eribulin arm were neutropenia, fatigue, nausea, alopecia and constipation, which is consistent with the known profile of eribulin.

Eisai in Oncology

Our commitment to meaningful progress in oncology research, built on scientific expertise, is supported by a global capability to conduct discovery and preclinical research, and develop small molecules, therapeutic vaccines, and biologic and supportive care agents for cancer across multiple indications.

About Eisai Co., Ltd.

Eisai Co., Ltd. is a leading global research and development-based pharmaceutical company headquartered in Japan. We define our corporate mission as "giving first thought to patients and their families and to increasing the benefits health care provides," which we call our human health care (hhc) philosophy. With over 10,000 employees working across our global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to realise our hhcphilosophy by delivering innovative products in multiple therapeutic areas with high unmet medical needs, including Oncology and Neurology.

As a global pharmaceutical company, our mission extends to patients around the world through our investment and participation in partnership-based initiatives to improve access to medicines in developing and emerging countries.

For more information about Eisai Co., Ltd., please visit http://www.eisai.com.

References

1. Schöffski P et al. Eribulin versus dacarbazine in previously treated patients with advanced liposarcoma or leiomyosarcoma: a randomised, open-label, multicentre, phase 3 trial. The Lancet. 2016

2. IQWiG Assessment Report. Available at: https://www.iqwig.de/download/A16-31_Eribulin_Kurzfassung_Nutzenbewertung-35a-SGB-V.pdf Accessed September 2016

3. Chawla S, et al. Subtype specific activity in liposarcoma (LPS) patients (pts) from a phase 3, open label, randomised study of eribulin (ERI) versus dacarbazine (DTIC) in patients with advanced LPS and leiomyosarcoma (LMS). American Society for Clinical Oncology annual meeting 2016; Abstract # 11037

4. Macmillan. What are soft tissue sarcomas? Available at: http://www.macmillan.org.uk/Cancerinformation/Cancertypes/Softtissuesarcomas/Aboutsofttissuesarcomas/Softtissuesarcomas.aspx . Accessed: November 2015

5. ESMO Guidance. Available at: http://annonc.oxfordjournals.org/content/25/suppl_3/iii102.full.pdf+html Accessed: November 2015

6. Schwartz RA. Liposarcoma. Medscape. 2013. Available at: http://emedicine.medscape.com/article/1102007-overview ; Accessed April 2016

7. Howlader N, Noone AM, Krapcho M, Miller D, Bishop K, Altekruse SF, Kosary CL, Yu M, Ruhl J, Tatalovich Z, Mariotto A, Lewis DR, Chen HS, Feuer EJ, Cronin KA (eds). SEER Cancer Statistics Review, 1975-2013, National Cancer Institute. Bethesda, MD, http://seer.cancer.gov/csr/1975_2013/ , based on November 2015 SEER data submission, posted to the SEER web site, April 2016

8. Robert Koch Institute, Krebs in Deutschland 2012. 70-73

9. SPC Halaven (updated August 2016). Available at: http://www.medicines.org.uk/emc/medicine/24382 Accessed: August 2016

10. R Pollock. Soft Tissue Sarcomas, A Volume in the American Cancer Society Atlas of Clinical Oncology Series. 2012

11. Fletcher, et al. World Health Organization Classification of Tumours of Soft Tissue and Bone (4th Edition). Lyon: IARC Press, 2013


Source: Eisai

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