- The phase 1b study showed a complete response (CR) rate of 46%
(objective response rate [ORR] of 88%) at the recommended dose
level in patients with relapsed/refractory (R/R) Hodgkin lymphoma,
whereas in a separate study MSD’s KEYTRUDA demonstrated an ORR of
69% and a CR of 22.4% as a monotherapy
- Investigators
concluded that AFM13 in combination with KEYTRUDA for R/R Hodgkin
lymphoma patients was well-tolerated with adverse events that were
generally manageable
- Novel immunotherapy
combination worthy of further investigation
Heidelberg, Germany, November 19,
2020 – Affimed N.V. (Nasdaq: AFMD), a clinical-stage
immuno-oncology company committed to giving patients back their
innate ability to fight cancer, today announced that the Phase 1b
study of AFM13, a CD30/CD16A innate cell engager (ICE®), in
combination with KEYTRUDA was published in Blood, the renowned
Journal of the American Society of Hematology. The results
demonstrate promising signs of efficacy including an objective
response rate (ORR) of 88% at the highest treatment dose, as well
as a complete CR of 46%. As a monotherapy, KEYTRUDA demonstrated an
ORR of 69% and a CR of 22.4% in the KEYNOTE-087 trial.
“We showed for the first time that the
combination of an ICE® with a PD-1 checkpoint inhibitor can be
safely administered with manageable side effects,” said Dr. Andreas
Harstrick, Chief Medical Officer at Affimed. “The high objective
response rate and complete response rate seen in this
proof-of-concept study of AFM13 combined with KEYTRUDA are very
encouraging and indicate that the activation of innate immunity
could improve upon current therapies.”
The study assessed the safety and efficacy of
AFM13 in combination with KEYTRUDA in 30 heavily pre-treated
patients with R/R Hodgkin lymphoma. The safety profile for the
combination was described as well-tolerated and similar to the
known profiles for each agent alone. Most adverse events were low
grade and remained manageable with standard-of-care therapies.
AFM13 presents a novel approach of activating
innate immunity through CD16A-directed tumor-cell killing by NK
cells and macrophages. The phase 1b study supports the notion that
in combination with an established therapy such as an immune
checkpoint inhibitor, that releases the brakes on adaptive immune
responses, the ICE® AFM13 complements the PD-1 checkpoint
inhibitor, thereby triggering both arms of the immune system
against tumors.
Dr. Nancy Bartlett, a medical oncologist and
Koman Chair in Medical Oncology at Washington University School of
Medicine in St. Louis and lead author on the publication, said,
“There is an unmet need for patients with Hodgkin lymphoma who have
relapsed or are refractory to current therapies. For these
patients, there are no therapies that show durable efficacy. The
combination of AFM13 with KEYTRUDA was well tolerated and showed an
88% response rate with a very encouraging 46% complete metabolic
response rate in a heavily pretreated patient population.
This exciting data shows that there are potential treatments on the
horizon for patients with limited options.”
“Engagement of the innate immune system to kill tumors is novel.
The studies of AFM13 and KEYTRUDA in Hodgkin lymphoma, as well as
AFM13 in patients with T-cell lymphoma, present exciting approaches
to controlling blood cancers that could significantly benefit
patients,” said Lee Greenberger, Ph.D., Chief Scientific Officer of
The Leukemia & Lymphoma Society (LLS), which supported
Affimed’s clinical study of AFM13 through its Therapy Acceleration
Program® (TAP), LLS’s strategic venture philanthropy funding
initiative.
More details about the Phase 1b of AFM13 in
combination with KEYTRUDA study can be found at
www.clinicaltrials.gov using the identifier NCT02665650. The
article published in Blood, Volume 136, Number 21 can be found here
https://bit.ly/2KiL293 .
About AFM13
AFM13 is a first-in-class innate cell engager that induces
specific and selective killing of CD30-positive tumor cells by
engaging and activating natural killer (NK) cells and macrophages,
thereby leveraging the power of the innate immune system. AFM13 is
Affimed’s most advanced ICE® clinical program, and it is currently
being evaluated as a monotherapy in a registration-directed trial
in patients with relapsed/refractory peripheral T-cell lymphoma or
transformed mycosis fungoides (REDIRECT). The study is actively
recruiting and can be found at www.clinicaltrials.gov using the
identifier NCT04101331.
Affimed is currently studying AFM13 in combination with cord
blood-derived allogeneic natural killer cells in cooperation with
the MD Anderson Cancer Center in Houston. The
investigator-sponsored Phase 1 study is preparing to administer a
stable complex of AFM13 pre-mixed with cord blood-derived
allogeneic NK cells, the study can be found at
www.clinicaltrials.gov using the identifier NCT04074746.
About Affimed N.V.
Affimed (Nasdaq: AFMD) is a clinical-stage immuno-oncology
company committed to giving patients back their innate ability to
fight cancer. Affimed’s fit-for-purpose ROCK® platform allows
innate cell engagers to be designed for specific patient
populations. The company is developing single and combination
therapies to treat hematologic and solid tumors. The company is
currently enrolling patients into a registration-directed study of
AFM13 for CD30-positive relapsed/refractory peripheral T cell
lymphoma and into a Phase 1/2a dose escalation/expansion study of
AFM24 for the treatment of advanced EGFR-expressing solid tumors.
For more information, please visit www.affimed.com.
About The Leukemia & Lymphoma Society and
Therapy Acceleration Program® (TAP)
The Leukemia & Lymphoma Society® (LLS) is a global leader in
the fight against cancer. The LLS mission: cure leukemia, lymphoma,
multiple myeloma, and improve the quality of life of patients
and their families. LLS TAP is a strategic initiative that builds
business alliances and collaborations with biotechnology companies
and academic researchers to identify potential breakthrough
therapies with the potential to change the standard of care. LLS
TAP funds late stage pre-clinical studies, and proof of concept or
registrational clinical trials to help advance these more quickly
along the drug development and approval pathway. To learn more,
visit www.LLS.org.
FORWARD-LOOKING STATEMENTS
This press release contains forward-looking
statements. All statements other than statements of historical fact
are forward-looking statements, which are often indicated by terms
such as “anticipate,” “believe,” “could,” “estimate,” “expect,”
“goal,” “intend,” “look forward to,” “may,” “plan,” “potential,”
“predict,” “project,” “should,” “will,” “would” and similar
expressions. Forward-looking statements appear in a number of
places throughout this release and include statements regarding our
intentions, beliefs, projections, outlook, analyses and current
expectations concerning, among other things, the potential of
AFM24, the value of our ROCK® platform, our ongoing and planned
preclinical development and clinical trials, our collaborations and
development of our products in combination with other therapies,
the timing of and our ability to make regulatory filings and obtain
and maintain regulatory approvals for our product candidates, our
intellectual property position, our collaboration activities, our
ability to develop commercial functions, clinical trial data, our
results of operations, cash needs, financial condition, liquidity,
prospects, future transactions, growth and strategies, the industry
in which we operate, the trends that may affect the industry or us,
impacts of the COVID-19 pandemic, the benefits to Affimed of orphan
drug designation and the risks, uncertainties and other factors
described under the heading “Risk Factors” in Affimed’s filings
with the Securities and Exchange Commission. Given these risks,
uncertainties and other factors, you should not place undue
reliance on these forward-looking statements, and we assume no
obligation to update these forward-looking statements, even if new
information becomes available in the future.
Affimed Investor and Media Contacts
Alex Fudukidis Head of Investor Relations
a.fudukidis@affimed.com
Mary Beth Sandin Head of Marketing and Communications
m.sandin@affimed.com
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