New Data for Eisai's Halaven® (eribulin) and Lenvima® (lenvatinib) in Hard to Treat Cancers will be Presented at Forthco

HATFIELD, England, May 24, 2016 /PRNewswire/ --

FOR EMEA MEDIA ONLY - NOT FOR SWISS/AUSTRIAN JOURNALISTS 

ASCO invites six abstracts on new Halaven(R) (eribulin) data in liposarcoma and solid

tumours, and new lenvatinib data in thyroid cancers and in renal cell carcinoma 

Six abstracts that feature new study results in hard to treat cancers for Eisai's treatments eribulin and lenvatinib will be presented during the 52nd Annual Meeting of the American Society of Clinical Oncology (ASCO), Chicago, 3-7 June 2016. These data provide new clinical evidence on the efficacy and safety of these two agents in a variety of cancers.

New lenvatinib data in thyroid cancer and renal cell cancer 

New efficacy data with a focus on duration of response from the SELECT study[1] show improved duration of response to lenvatinib for patients with radioiodine-refractory differentiated thyroid cancer compared with placebo. Updated results show that 157 patients (60.2%) respond to lenvatinib and the median duration of response is 30 months (95% CI 18.4-35.2), compared with three patients (2.3%) with placebo and a median duration of response of 14.7 months (95% CI 7.5-not evaluable).  Median duration of overall response is similar by subgroup, except for patients with greater disease burden and those with liver metastasis.  

The final results of a single-arm open-label Phase II study[2] of lenvatinib in 51 patients with differentiated, medullary and anaplastic thyroid cancer show tumour shrinkage in almost all patients, and with manageable toxicities.

In a subgroup analysis of a Phase II study in renal cell carcinoma progression free survival benefit is maintained in high risk poor prognosis renal cancer subgroups[2] (MSKCC risk, baseline tumour size, metastasis site). Updated overall survival in the intent-to-treat population shows a trend towards improved overall survival for lenvatinib plus everolimus compared with everolimus.

New eribulin data in soft tissue sarcoma and in solid tumours 

Significant benefit in overall survival is observed for eribulin compared with dacarbazine in patients with liposarcoma according to a subtype-specific analysis[3] of a Phase III study.[4]  The Phase III study included patients with leiomyosarcomas or liposarcomas and results for both tumour types are published in the Lancet.[4]

In an exploratory analysis evaluating the quality of life at progression in the same Phase III study[5], there were notable increases in severity of symptoms among patients treated with dacarbazine compared with eribulin.

A phase I study shows that a liposomal formulation of eribulin is well tolerated and has promising activity in patients with solid tumours.[5]

"The results being presented at ASCO underscore Eisai's ongoing commitment to support patients with difficult to treat cancers for which there are currently too few treatment options. As part of our human health care mission we are committed to investing in innovative therapies that have the potential to improve the lives of patients and their families and deliver meaningful progress in the battle against cancer," said Kenichi Nomoto, Ph.D., Chief Scientific Officer of the Oncology Business Group, Eisai.

The full details of the six abstracts are as follows:

Presentation

Product Abstract Name Details

Lenvatinib Phase II study of lenvatinib in patients Poster

Abstract No: with differentiated, medullary, and Presentation:

6088 anaplastic thyroid cancer: final analysis Head and Neck

results Cancer

Takahashi S, et al Date: 4 June

Time: 1:00-4:30 PM

Lenvatinib Duration of response to lenvatinib Poster

Abstract No: treatment in patients with Presentation:

6089 radioiodine-refractory differentiated Head and Neck

thyroid cancer (RR-DTC) Cancer

Gianoukakis A, et al Date: 4 June

Time: 1:00-4:30 PM

Lenvatinib Subgroup analyses from the phase 2 trial Poster

Abstract No: of lenvatinib (LEN), everolimus (EVE), Presentation:

4553 and LEN+EVE in metastatic renal cell Genitourinary

carcinoma (mRCC) (Non-prostate)

Hutson T, et al Cancer

Date: 6 June

Time: 1:00-4:30 PM

Eribulin Phase 1 multicenter, open label study to Poster

Abstract No: establish the maximum tolerated dose Presentation:

2524 (MTD) of two administration schedules of Developmental

E7389 (eribulin) liposomal formulation in Therapeutics-Clini

patients (pts) with solid tumours cal Pharmacology

Zubairi I, et al and Experimental

Therapeutics

Date: 5 June

Time: 8:00-11:30 AM

Eribulin Subtype specific activity in liposarcoma Poster

Abstract No: (LPS) patients (pts) from a phase 3, open Presentation:

11037 label, randomised study of eribulin (ERI) Sarcoma

versus dacarbazine (DTIC) in patients Date: 6 June

with advanced LPS and leiomyosarcoma(LMS) Time:8:00-11:30 AM

Chawla S, et al

Eribulin Evaluation of quality of life at Poster

Abstract No: progression in patients with soft tissue Presentation:

11015 sarcoma Sarcoma

Hudgens S, et al Date: 6 June

Time: 8:00-11.30 AM

Eribulin is indicated in Europe for the treatment of women 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 unless patients were not suitable for these treatments.[6]

The European Commission has recently approved a variation to the terms of the Marketing Authorisation 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.

Lenvatinib is indicated in Europe for the treatment of adult patients with progressive locally advanced or metastatic, differentiated (papillary, follicular, Hürthle cell) thyroid carcinoma (DTC) refractory to radioactive iodine (RAI).[7]

Notes to Editors  

Eisai in Oncology  

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