STOCKHOLM, Dec. 8, 2019 /PRNewswire/ -- Oncopeptides
AB (Nasdaq Stockholm: ONCO) will today present updated
data from the ongoing Phase 2 ANCHOR (OP-104) triple combination
study at the ASH Annual Meeting 2019. In the data presented,
melflufen and dexamethasone demonstrated positive efficacy in
combination with daratumumab or bortezomib in patients with
relapsed/refractory multiple myeloma (RRMM). Preclinical data
supporting clinical development of melflufen in AL amyloidosis will
also be presented for the first time.
Overall Conclusions - ANCHOR Poster Presentation
- Patients in the ANCHOR study had a median of two prior lines of
therapy. All patients were refractory to at least one agent.
- For melflufen and dexamethasone in combination with daratumumab
(n=33) the overall response rate (ORR) was 76% with a median
progression-free survival (PFS) of 14.3 months.
- 70% of the patients were still progression-free at the time of
the data cut.
- For melflufen and dexamethasone in combination with bortezomib
(n=6) the ORR was 67%.
- Responses improved with continued therapy for both
combinations.
- Both combinations were well tolerated and the grade 3 and 4
Adverse Events (AE) were primarily hematologic.
Klaas Bakker, MD, and Chief
Medical Officer comments on the ANCHOR data
"The ANCHOR data presented today are truly encouraging and support
the future development of melflufen in triplet regimens. The ORR of
76% and median PFS of 14.3 months in the daratumumab arm, while
immature, are among the highest reported in this patient
population. This further validates the foundation for our next
pivotal randomized Phase 3 study LIGHTHOUSE (OP-108), in which we
will compare subcutaneous daratumumab with or without melflufen. We
expect to enroll the first patient in early 2020 and are excited to
embark on this next journey with melflufen in multiple
myeloma."
Klaas Bakker, MD, and Chief
Medical Officer comments on the AL amyloidosis data
"Based on our very positive preclinical data around AL amyloidosis
and our experience of melflufen in a clinical setting, we are
excited to initiate our first study with melflufen in patients with
Immunoglobulin Light Chain (AL) amyloidosis. This lays the
foundation for the use of melflufen in another indication with a
high unmet medical need."
The posters are available on the company webpage
under:
www.oncopeptides.com / Investor Relations / Presentations / ASH
2019
For more information, please contact:
Jakob Lindberg, CEO of
Oncopeptides
E-mail: jakob.lindberg@oncopeptides.com
Telephone: +46 8 615 20 40
Rein Piir, Head of Investor Relations at Oncopeptides
E-mail: rein.piir@oncopeptides.com
Cell phone: +46 70 853 72 92
The information in the press release is information that
Oncopeptides is obliged to make public pursuant to the EU Market
Abuse Regulation. The information was submitted for publication,
through the agency of the contact person above, on December 8, 2019 at 15.00 (CET).
About the OP-104 ANCHOR study
ANCHOR is a phase 1/2 study where melflufen and dexamethasone is
dosed in combination with either bortezomib or daratumumab. All
patients enrolled must have had 1-4 prior lines of therapy and be
refractory (or intolerant) to an immunomodulary agent (IMiD) or a
proteasome inhibitor (PI) or both. The enrollment in the
daratumumab regimen is completed while recruitment for the
bortezomib arm is still ongoing.
More information about the study can be found at:
https://clinicaltrials.gov/ct2/show/NCT03481556?term=melflufen&rank=4
About the OP-102 AL amyloidosis study
The AL amyloidosis study is an Open-label, Phase 1/2
dose-escalation and dose-expansion study of melflufen and
dexamethasone in patients with immunoglobulin light chain (AL)
amyloidosis following at least one prior line of therapy. The study
will enroll approximately 45 patients. The primary endpoint in the
phase 2 part is to study the Overall Response Rate (ORR).
More information about the study can be found at:
https://clinicaltrials.gov/ct2/show/NCT04115956?term=melflufen&rank=4
About melflufen
Melflufen is a novel peptide-drug conjugate that rapidly delivers a
cytotoxic payload into tumor cells. Melflufen is rapidly taken up
by myeloma cells due to its high lipophilicity and is immediately
cleaved by peptidases to deliver an entrapped hydrophilic alkylator
payload. Peptidases play a key role in protein homeostasis and
feature in cellular processes such as cell-cycle progression and
programmed cell death. In vitro, melflufen is 50-fold more potent
in myeloma cells than the alkylator payload itself due to the
increased intracellular alkylator concentration. Melflufen displays
cytotoxic activity against myeloma cell lines resistant to other
treatments, including alkylators, and has also demonstrated
inhibition of DNA repair induction and angiogenesis in preclinical
studies.
About Oncopeptides
Oncopeptides is a pharmaceutical company focused on the development
of targeted therapies for difficult-to-treat hematological
diseases. The company is focusing on the development of the lead
product candidate melflufen, a novel peptide-drug conjugate that
rapidly delivers a cytotoxic payload into tumor cells. Melflufen is
in development as a new treatment for the hematological cancer
multiple myeloma and is currently being tested in multiple clinical
studies including the pivotal phase 2 HORIZON study and the ongoing
phase 3 OCEAN study. Oncopeptides' headquarters is in Stockholm, Sweden, and the company is listed
in the Mid Cap segment on Nasdaq Stockholm with the ticker
ONCO.
More information is available on www.oncopeptides.com.
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Press Release ANCHOR
Dec 8, 2019
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