Merck 2014 Annual Report Download - page 76

71GROUP MANAGEMENT REPORT → FUNDAMENTAL INFORMATION ABOUT THE GROUP → Research and development at the group
Concerning tecemotide, an investigational cancer immunotherapy
(also known as L-BLP25), a PhaseIII study called START2 was
initiated in April2014, following the results of the START study
of tecemotide in stage III NSCLC. Although START did not meet
its primary endpoint of demonstrating an improved OS with tec-
emotide compared with placebo in the overall patient population,
data from an exploratory analysis of a pre-defined subgroup of
patients who received tecemotide after concurrent chemo-
radiotherapy (CRT), showed that these patients survived longer.
However in September, the results of study EMR 63325-009,
a PhaseI / II trial in Japanese patients with stageIII, unresectable,
locally advanced NSCLC, the majority of whom had received
concurrent CRT, indicated that no effect had been observed for
either the primary endpoint, OS, or for any of the secondary
efficacy endpoints. Based on these results, the Biopharmaceuticals
division decided to discontinue the clinical development program
for tecemotide.
After a careful analysis of its pipeline assets the Biopharma-
ceuticals division decided to discontinue development of NHS-IL2
(MSB0010445), also known as Selectikine, which was in PhaseII
testing in advanced melanoma. This decision was not related to
any new safety or efficacy findings. It will allow the company to
refocus its efforts on other pipeline candidates.
Merck KGaA, Darmstadt, Germany, and MorphoSys entered
into a strategic immuno-
oncology collaboration to discover and
develop therapeutic antibodies against immune checkpoints. Un-
der the terms of the agreement, the two companies will join forces
to develop therapies that modulate the immune system’s natural
ability to fight tumors. MorphoSys will apply its proprietary
Ylanthia® antibody phage library and technology platform to
identify antibodies against
targets of interest. With its strong
portfolio and capabilities in the
field of immuno-oncology and
clinical development, the Biopharmaceuticals division will be
fully responsible for execution of development from Phase I
on wards.
Immunology
In the field of Immunology, a Phase IIb study of atacicept, an anti-
Blys and anti-APRIL fusion protein, in patients with systemic
lupus erythematosus (SLE) was initiated. This study is known as
ADDRESS II and follows the promising results of the completed
APRIL SLE study which were presented at the Annual Meeting of
the European League against Rheumatism (EULAR) in 2013.
ADDRESS II is a double-blind, placebo-controlled study of
atacicept given at two doses in 279 patients with active SLE to
assess its efficacy and safety in reducing SLE-disease activity in
patients receiving standard-of-care therapy. The outcome of this
study is expected in 2016. A two-year long-term extension study
(ADDRESS II LTE) has also been initiated in order to develop
atacicept’s safety database.
Also aiming at the treatment of SLE, an agreement was entered
into by Merck KGaA, Darmstadt, Germany, Pfizer Inc. and the
Broad Institute in Cambridge, Massachusetts, in April. The collab-
oration is focused on the genomic profiling of patients with SLE
and lupus nephritis. The goal of this research project, which will
be jointly funded by Merck KGaA, Darmstadt, Germany, and
Pfizer, is to identify biomarkers to better define target patient
populations for future therapies as well as to discover potential
novel drug targets for innovative therapies.
The FORWARD study, a PhaseII trial of sprifermin, an inves-
tigational fibroblast growth factor given at four doses vs placebo
in patients with primary osteoarthritis of the knee, is being con-
ducted in collaboration with the Group’s strategic alliance partner,
Nordic Bioscience Clinical Development. The study completed
enrollment in mid-2014, following the inclusion of 549patients,
and the outcome of the study is expected to become available in
2016. Following the completion of a Phase I study in healthy
volunteers of the anti-IL-17-A/F nanobody, MSB 0010841 (also
known
as ALX-0761), a Phase Ib study in patients with psoriasis
has been initiated.
A small-molecule BTK inhibitor (MSC 2364447) entered Phase
I clinical testing in healthy volunteers in the third quarter of
2014. This investigational agent is a highly selective inhibitor of
the Bruton’s tyrosine kinase (BTK), which is important in the
development and functioning of various immune cells including
B lymphocytes and macrophages. Preclinical research suggests it
may be therapeutically useful in certain autoimmune diseases.