SHANGHAI, June 11, 2021 /PRNewswire/ -- Shanghai Yingli
Pharmaceuticals Ltd (Yingli Pharma), a clinical stage
pharmaceutical company providing new therapies for cancer and
metabolic diseases, announced today the topline data from a
clinical trial sponsored by the company at the annual meeting of
the European Hematology Association (EHA) being held June 9-17, 2021.
The study entitled 'A Phase 2 study of an oral PI3Kδ
inhibitor YY-20394 in patients with relapsed or refractory
follicular lymphoma' will be presented at EHA by Dr.
Lugui Qiu, a lead investigator from
Institute of Hematology and Blood Diseases Hospital, Chinese
Academy of Medical Sciences, Tianjin,
China. This is a registration study that enrolled 93
relapsed or refractory Follicular Lymphoma (FL) patients having
received 2 or more prior systemic therapies and was conducted at 32
clinical sites in China.
Linperlisib was evaluated as a monotherapy for safety, tolerability
and efficacy at recommended phase 2 dose of 80 mg once daily.
Following a data cutoff on March 15,
2021, the fully enrolled study was analyzed for 89 evaluable
patients. The Overall Response Rate (ORR) was 79.5%, with 12.4%
Complete Response, 67.4% Partial Response, and 16.1% Stable
Disease, combining to achieve a Disease Control Rate of 96.6%.
Previously, the Phase 1 study of linperlisib had shown similar
preliminary efficacy of 90% ORR in 10 patients with r/r FL. As of
the data cutoff for the Phase 2, the median Progression Free
Survival was 11.8 months, and the Duration of Response was 12.3
months. Forty seven patients were continuing to receive
linperlisib treatment.
Follicular Lymphoma is increasingly harder to treat if patients
progress on previous therapies, usually immuno-chemotherapy is a
mainstay as a prior treatment. On this study, 65% of the patients
had received 3 or more prior systemic treatments, and all patients
had previously received rituximab-based therapies.
The safety data from the FL Phase 2 study indicated that
linperlisib was generally safe and tolerable with manageable
adverse events. Most of the adverse events were Grade 1 and
Grade 2. The most common (>5%) treatment related hematologic
adverse events of ≥ Grade 3 were neutropenia (15.1%),
leukocytopenia (5.4%), lymphocytopenia (5.4%). The most common
(>5%) treatment related non-hematologic adverse events of ≥
Grade 3 were pneumonia (15.1%).
Dr. Lugui Qiu, a prinicipal
investigator on the study, stated "FL is complicated as the
relapsed and refractory patients tend to progress rapidly,
requiring aggressive therapies. From the clinical findings with
linperlisib treatment of FL patients, we are seeing durable
responses for most patients. Patients are in desperate need of
effective therapies that target these lymphoma key signaling
pathways and therapies that are oral medications, easy for patients
to use outside of a clinic."
Dr. Zusheng Xu, General Manager of Yingli Pharma commented "We
are excited to be developing Linperlisib for the treatment of
lymphomas and solid tumors. Linperlisib is a next-generation
PI3Kδ-selective inhibitor. The clinical data suggest that
Linperlisib might be a potentially advantageous treatment option
for patients. We have applied a linperlisib marketing approval in
China in relapsed or refractory
FL, based on the data from this phase II registration study. We
hope to broaden the use of linperlisib and are exploring its
anti-tumor activities in different indications in additional
clinical trials."
Dr. Qiu also indicated "It is a major step that Linperlisib has
been accepted by the NMPA for the NDA application, and we are very
optimistic about the outcome."
About Linperlisib
Linperlisib (YY-20394) is a highly selective and potent
PI3Kδ inhibitor that has shown a favorable safety profile,
exciting anti-tumor activities, and good PK and pharmaceutical
properties as an oral once-a-day agent in late-stage clinical
development. A phase 1 clinical trial was completed in 2020
demonstrating linperlisib to be a safe and tolerable agent, and a
recommended phase 2 dose of 80 mg QD was established. Linperlisib
was awarded NMPA Breakthrough Therapy status in China, leading to the current trial. In
addition, linperlisib received FDA Orphan Drug Designations for FL,
CLL/SLL, and T cell lymphoma. A clinical trial in r/r FL is
launching in the US. Multiple linperlisib clinical trials being
conducted in other lymphomas, solid tumors, and in combination with
gemcitabine/oxaliplatin in r/r DLBCL. Preliminary results from a
PTCL Phase1b study were reported at ASCO 2021, indicating an
overall response rate of 70% with 33% CRs in 30 evaluable patients
with r/r PTCL, a difficult to treat and aggressive form of
lymphoma.
About Yingli Pharma
Yingli Pharma, headquartered in Shanghai with a subsidiary in San Francisco, is an innovative clinical
stage biopharmaceutical company. Yingli Pharma is developing
best-in-class and first-in-class oral investigational agents for
the treatment of cancer, metabolic and autoimmune diseases. Yingli
Pharma currently has three investigational agents in clinical
development, linperlisib (YY-20394) and YL-13027 in advanced
cancers, as well as YL-90148, an investigational oral URAT-1
inhibitor for the treatment of in hyperuricemia/gout. Several
additional oncology programs are in IND-enabling or candidate
development stages.
For more information about Yingli Pharma and the investigational
agent portfolio, see http://www.yl-pharma.com/
For further information, please contact Jin Qin. Tel.: (86)21-50200566, Email:
jqin@yl-pharma.com
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SOURCE Shanghai Yingli Pharmaceutical Co., Ltd.