Approval decision expected in 4Q 2022
ADC Therapeutics SA (NYSE: ADCT) and Swedish Orphan Biovitrum AB
(Sobi®) today announced the Committee for Medicinal Products for
Human Use (CHMP) of the European Medicines Agency has adopted a
positive opinion recommending the marketing authorization of
ZYNLONTA® (loncastuximab tesirine) for the treatment of relapsed or
refractory diffuse large B-cell lymphoma (DLBCL). The positive
opinion from the CHMP is now referred to the European Commission
for an approval decision.
Earlier this year, ADC Therapeutics announced an exclusive
license agreement with Sobi to develop and commercialize ZYNLONTA
for all hematologic and solid tumor indications in Europe and
select international territories.
“The positive CHMP opinion demonstrates significant progress
toward bringing ZYNLONTA to DLBCL patients in Europe,” said Ameet
Mallik, Chief Executive Officer of ADC Therapeutics. “We are
committed, along with our partners, to making ZYNLONTA available to
as many patients as possible worldwide and look forward to the
European Commission’s final decision, which is anticipated in the
fourth quarter of 2022.”
“Today’s announcement marks an important step toward meeting the
critical needs of patients with relapsed and refractory large
B-cell lymphoma across the EU,” said Anders Ullman, Head of
Research & Development and Chief Medical Officer at Sobi. “We
believe Sobi's heritage and strong presence in hematology will
provide a competitive platform for bringing loncastuximab tesirine
to more patients.”
The opinion is based on data from LOTIS-2, a large (n=145) Phase
2 multinational, single-arm clinical trial of ZYNLONTA for the
treatment of adult patients with relapsed or refractory DLBCL
following two or more prior lines of systemic therapy. In April
2021, the U.S. Food and Drug Administration (FDA) granted
accelerated approval of ZYNLONTA as the first CD19-targeted
antibody drug conjugate (ADC) as a single-agent treatment for adult
patients with relapsed or refractory DLBCL after two or more lines
of systemic therapy. In September 2021, the European Commission
granted Orphan Drug Designation to ZYNLONTA for the treatment of
DLBCL.
“The results of the LOTIS-2 study demonstrated significant
clinical benefit for patients with recurrent diffuse large B-cell
lymphoma, an aggressive subtype of non-Hodgkin lymphoma,” said John
Radford, Professor of Medical Oncology at The University of
Manchester and The Christie NHS Foundation Trust in Manchester, UK.
“I am encouraged by the potential of ZYNLONTA to help patients in
this underserved treatment population. If approved by the European
Commission, ZYNLONTA will offer a new therapeutic option to
patients with this difficult to treat lymphoma and gives hope to
them and their families.”
ADC Therapeutics has an exclusive license agreement with
Mitsubishi Tanabe Pharma Corporation (MTPC) for the development and
commercialization of ZYNLONTA for all hematologic and solid tumor
indications in Japan. In addition, Overland ADCT BioPharma, a joint
venture formed by Overland Pharmaceuticals and ADC Therapeutics, is
working to develop and commercialize ZYNLONTA in greater China and
Singapore. Overland ADCT BioPharma is now conducting a
registrational pivotal Phase 2 clinical trial of ZYNLONTA in
relapsed or refractory DLBCL in China.
About ZYNLONTA® (loncastuximab tesirine-lpyl)
ZYNLONTA® is a CD19-directed antibody drug conjugate (ADC). Once
bound to a CD19-expressing cell, ZYNLONTA is internalized by the
cell, where enzymes release a pyrrolobenzodiazepine (PBD) payload.
The potent payload binds to DNA minor groove with little
distortion, remaining less visible to DNA repair mechanisms. This
ultimately results in cell cycle arrest and tumor cell death.
The U.S. Food and Drug Administration (FDA) has approved
ZYNLONTA (loncastuximab tesirine-lpyl) for the treatment of adult
patients with relapsed or refractory (r/r) large B-cell lymphoma
after two or more lines of systemic therapy, including DLBCL not
otherwise specified, DLBCL arising from low-grade lymphoma and also
high-grade B-cell lymphoma. The trial included a broad spectrum of
heavily pre-treated patients (median three prior lines of therapy)
with difficult-to-treat disease, including patients who did not
respond to first-line therapy, patients refractory to all prior
lines of therapy, patients with double/triple hit genetics and
patients who had stem cell transplant and CAR-T therapy prior to
their treatment with ZYNLONTA. This indication is approved by the
FDA under accelerated approval based on overall response rate and
continued approval for this indication may be contingent upon
verification and description of clinical benefit in a confirmatory
trial.
ZYNLONTA is also being evaluated as a therapeutic option in
combination studies in other B-cell malignancies and earlier lines
of therapy.
About ADC Therapeutics
ADC Therapeutics (NYSE: ADCT) is a commercial-stage
biotechnology company improving the lives of those affected by
cancer with its next-generation, targeted antibody drug conjugates
(ADCs). The Company is advancing its proprietary PBD-based ADC
technology to transform the treatment paradigm for patients with
hematologic malignancies and solid tumors.
ADC Therapeutics’ CD19-directed ADC ZYNLONTA® (loncastuximab
tesirine-lpyl) is approved by the FDA for the treatment of relapsed
or refractory diffuse large b-cell lymphoma after two or more lines
of systemic therapy. ZYNLONTA is also in development in combination
with other agents. Cami (camidanlumab tesirine) is being evaluated
in a pivotal Phase 2 trial for relapsed or refractory Hodgkin
lymphoma and in a Phase 1b clinical trial for various advanced
solid tumors. In addition to ZYNLONTA and Cami, ADC Therapeutics
has multiple ADCs in ongoing clinical and preclinical
development.
ADC Therapeutics is based in Lausanne (Biopôle), Switzerland and
has operations in London, the San Francisco Bay Area and New
Jersey. For more information, please visit
https://adctherapeutics.com/ and follow the Company on Twitter and
LinkedIn.
ZYNLONTA® is a registered trademark of ADC Therapeutics SA.
About Sobi
Sobi is a specialised international biopharmaceutical company
transforming the lives of people with rare diseases. Providing
sustainable access to innovative medicines in the areas of
haematology, immunology and specialty care, Sobi has approximately
1,600 employees across Europe, North America, the Middle East and
Asia. In 2021, revenue amounted to SEK 15.5 billion. Sobi’s share
(STO:SOBI) is listed on Nasdaq Stockholm. More about Sobi at
sobi.com, LinkedIn and YouTube.
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Investors Eugenia Litz ADC Therapeutics
Eugenia.Litz@adctherapeutics.com Tel.: +44 7879 627205 Amanda
Loshbaugh ADC Therapeutics Amanda.Loshbaugh@adctherapeutics.com
Tel.: +1 917-288-7023 Media Mary Ann Ondish ADC Therapeutics
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