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Yesterday, we reviewed the top 10 potential blockbuster therapies
that could be approved this year.
Today, let's look ahead to the clinical trials
worth watching in 2023.
Recently, Evaluate released a report that inventoried 26 clinical development programs expected to achieve results in 2023, including a total of 32 clinical trials
.
In today's article, WuXi AppTec's content team will also introduce these investigational therapies
to readers and friends by disease type.
.
lung cancer
lung cancerIn many clinical projects, cancer therapy still occupies a major position, and lung cancer is the focus
of research and development in cancer.
If you want to break down these lung cancer therapies further, the first thing worth discussing are two anti-TIGIT therapies
.
As an emerging target in recent years, TIGIT has attracted the attention of many pharmaceutical companies, but the failure of a clinical trial in March last year cast a shadow
over the research and development prospects of this target.
The trial results of other clinical programs will attract widespread attention
from the industry.
.
ROCHE'S TIRAGOLUMAB IS EXPECTED TO ANNOUNCE PRELIMINARY RESULTS FROM ITS PHASE 3 CLINICAL TRIAL, SKYSCRAPER-01, IN THE FIRST QUARTER OF THIS YEAR, WHILE FULL DATA IS EXPECTED IN THE SECOND HALF OF THIS YEAR
.
The trial will evaluate whether tiragolumab in combination with the PD-L1 inhibitor Tecentriq (atezolizumab) can achieve better results
than Tecentriq alone.
Overall survival (OS) will be one of the primary endpoints of
the study.
In addition, Merck's vibostolimab will also be used with PD-1 inhibitor Keytruda (pembrolizumab) as a combination therapy Phase 2 clinical data is also expected to be released
this year.
The trial was designed to assess whether combination therapy, or a combination of combination therapy and chemotherapy, is superior to chemotherapy
.
Secondly, a number of antibody conjugate drugs will also be announced this
year.
Led by Daiichi
Sankyo) and AstraZeneca, developed datopotamab
Deruxtecan will announce the results of its Phase 3 clinical trial in the
first half of this year.
This antibody conjugate targets the Trop2 target and will be compared to
chemotherapy.
Another antibody-conjugated drug, patritumab
Deruxtecan was also developed by Daiichi Sankyo and targets HER3
.
The trial compared the effects of different doses of the drug, with the primary endpoint being objective response rate
.
year.
In addition, the third-generation EGFR tyrosine kinase inhibitor lazertinib developed by Johnson & Johnson's Janssen and the EGFR/MET bispecific antibody Rybrevant (amivantamab) are expected to have trial results
in the middle of this year.
The trial was divided into three groups, one with a chemotherapy control, one receiving chemotherapy in combination with Rybrevant, and one in addition to chemotherapy, plus Rybrevant and lazertinib
.
The trial is expected to reveal the efficacy
of these two drugs in patients with non-small cell lung cancer with specific EGFR mutations.
in the middle of this year.
breast cancer
breast cancerIn addition to lung cancer, breast cancer is also the focus
of cancer developers.
This year, the blockbuster antibody-conjugate drug Enhertu (trastuzumab
Deruxtecan) will welcome the announcement of a Phase 3 clinical trial
.
The trial will compare Enhertu with chemotherapy in patients with low levels of HER2 expression
.
Early data presented at last year's ASCO meeting suggested that the therapy could achieve significant improvements
in this population.
ASCO officials also pointed out that this result rewrites the definition of breast cancer and is a milestone.
of cancer developers.
This year, the blockbuster antibody-conjugate drug Enhertu (trastuzumab Deruxtecan) will welcome the announcement of a Phase 3 clinical trial
.
By Eli Lilly (Eli
Lilly's imlunestrant is also worth paying attention to
.
This is an oral selective estrogen receptor degrader (SERD) that has shown early efficacy signals
in patients with advanced breast cancer who have been treated with multiple upfront therapies.
In the Phase 3 clinical trial, which is expected to publish results this year, researchers will evaluate the efficacy
of imlunestrant compared to standard hormone therapy.
The clinical trial treated patients
with ER-positive, HER2-negative breast cancer.
.
CDK inhibitors are also a common treatment for breast cancer
.
Novartis' CDK4/6 inhibitor Kisqali (ribociclib), used in combination with endocrine therapy, announced preliminary results
in December for the treatment of HR-positive, HER2-negative breast cancer patients.
This year, we expect to see more Phase 3 clinical trial data
for this therapy.
AstraZeneca's combination therapy with the selective estrogen receptor-degrading drug Camizestrant and CDK4/6 inhibitors is also being tested in a Phase 3 clinical trial and is expected to announce results
in the fourth quarter of this year.
.
Other cancers
Other cancersIn addition to lung cancer and breast cancer, there are also a variety of cancer therapies that have also attracted a lot of attention
.
For example, the combination of Opdivo and Yervoy brought by Bristol-Myers Squibb (BMS) will announce the Phase 3 clinical results of the first-line treatment of liver cancer, comparing whether it can improve overall survival compared with standard treatment
.
Last year, the anti-CTLA-4 antibody Imjudo (tremelimumab) brought by AstraZeneca was approved for the treatment of patients with unresectable hepatocellular carcinoma
in combination with the anti-PD-L1 antibody Imfinzi (durvalumab).
These therapies are expected to benefit the vast number of liver cancer patients around the world and meet their unmet medical needs
.
.
For example, the combination of Opdivo and Yervoy brought by Bristol-Myers Squibb (BMS) will announce the Phase 3 clinical results of the first-line treatment of liver cancer, comparing whether it can improve overall survival compared with standard treatment
.
In the treatment of blood cancers, bispecific antibodies have become the focus
of attention.
The talquetab developed by Janssen and Genmab will announce further results
for the treatment of relapsed or refractory multiple myeloma in the second half of this year.
This is a potential "first-in-class" bispecific antibody that targets both GPRC5D and CD3 molecules, and last year published data from phase 1/2 clinical trials and completed the submission
of marketing applications.
epcoritamab, developed by AbbVie and Genmab, will also announce results
from a Phase 3 clinical trial for the treatment of diffuse large B-cell lymphoma later this year.
This is also a bispecific antibody that targets CD20 and CD3
.
The therapy was prioritized last November, and Evaluate's report notes that its Phase 3 clinical results are expected to be used to support full approval
of the drug.
of attention.
In the treatment of blood cancer, it is also expected to usher in potential "first-in-class" therapy
.
Novartis' sabatolimab, an antibody targeting TIM-3, may enhance their anti-leukemia activity
by binding to myeloid immune cells.
It also binds to leukemia stem cells and inhibits the self-renewal
of these stem cells.
This year we may see results
from its Phase 2 clinical trial for the treatment of acute myeloid leukemia (AML).
.
Weight loss therapy
Weight loss therapyWith the significant progress of some weight loss therapies in recent years, this field has received more and more attention
from the industry.
In 2023, several clinical programs will also be selected for the list, Novo Nordisk (Novo
Nordisk's semaglutide took three of the seats, while the remaining two projects came from Eli Lilly's Mounjaro (tirzepatide).
from the industry.
Novo Nordisk (Novo Nordisk's semaglutide took three of the seats, while the remaining two projects came from Eli Lilly's Mounjaro (tirzepatide).
In a phase 3 clinical trial, researchers will first evaluate the effectiveness of this therapy in obese heart failure patients, and observe changes in heart failure symptoms and weight before and after treatment
.
The trial is expected to announce its results
in the second quarter of this year.
A second phase 3 clinical trial will evaluate whether semeglutide reduces the risk of
cardiovascular events in patients with heart failure who are overweight or obese.
The final Phase 3 clinical program evaluated the effect of oral sermeglutide in lowering blood glucose in patients with type 2 diabetes and whether they lost weight
in overweight or obese patients.
Mounjaro's first clinical program involved three different clinical trials evaluating whether the therapy could reduce weight in people with diabetes, maintain or promote weight loss in patients with significant life changes, and maintain or lose weight
in obese or overweight patients.
The second clinical program will evaluate the safety and efficacy
of Mounjaro in obese heart failure patients.
According to Evaluate's report, the two clinical programs are expected to release more data
in the second quarter of this year and the second half of this year, respectively.
Other common diseases
Other common diseasesIn addition to the cancer therapy and weight loss therapy introduced above, the report of this evaluation also mentions three therapies
for other common diseases.
The first is the blockbuster treatment Dupixent (dupilumab) brought by Sanofi and Regeneron, which refers to chronic obstructive pulmonary disease (COPD).
The trial evaluates the efficacy, safety and tolerability of Dupixent, with results
expected in the first half of the year.
for other common diseases.
The first is the blockbuster treatment Dupixent (dupilumab) brought by Sanofi and Regeneron, which refers to chronic obstructive pulmonary disease (COPD).
The second treatment is Donanemab
, Lilly's potential Alzheimer's disease.
At the Alzheimer's Disease Clinical Trials Conference held at the end of 2022, Eli Lilly announced positive data from a Phase 3 clinical trial: after 6 months of treatment, Donanemab reduced amyloid plaque levels in the brains of patients with early-stage Alzheimer's disease by 65.
2% compared to 17.
0%
in the active control group.
By the middle of this year, we expect to see more data
on this therapy.
, Lilly's potential Alzheimer's disease.
The third therapy is PF-07252220 (BNT161), developed by Pfizer and BioNTech, an mRNA vaccine to prevent influenza that will be compared to conventional influenza vaccines in clinical trials to evaluate efficacy, safety and tolerability
.
If successful, it would be another breakthrough
for mRNA vaccines.
Rare diseases
Rare diseasesThere are also a number of therapies for rare diseases that are worth paying attention to this year, starting with two therapies targeting the complement pathway: Roche's crovalimab, a recyclable monoclonal antibody targeting complement protein C5, and phase 3 clinical results for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) are expected to be announced
earlier this year.
Novartis' complement factor B inhibitor iptacopan will also announce results from two Phase 3 clinical trials for the treatment of primary IgA nephropathy and C3 glomerulopathy
.
J&J's $6.
5 billion acquisition of Momenta's nipocalimab is an antibody therapy targeting the neonatal Fc receptor (FcRn) with the potential to
treat a variety of autoimmune diseases.
In the first half of this year, the treatment is expected to reveal the results of a phase 2 trial for the treatment of rheumatoid arthritis, and a phase 3 clinical trial for the treatment of myasthenia gravis may be released by the end of the year
.
5 billion acquisition of Momenta's nipocalimab is an antibody therapy targeting the neonatal Fc receptor (FcRn) with the potential to
treat a variety of autoimmune diseases.
Sanofi's Tolebrutinib, an oral Luton's tyrosine kinase (BTK) inhibitor capable of crossing the blood-brain barrier, has met its primary and secondary endpoints
in Phase 2b clinical trials for the treatment of patients with multiple sclerosis.
Currently, Sanofi is undergoing multiple Phase 3 clinical trials and is expected to announce the results by the
middle of this year.
in Phase 2b clinical trials for the treatment of patients with multiple sclerosis.
The last treatment on the list is Pfizer's hemophilia B gene therapy fidanacogene
elaparvovec
。 Data were revealed 4 days ago for this therapy and it reached its primary endpoint
.
Patients who received gene therapy achieved a non-inferior, or superior, annual bleeding rate compared with conventional therapy
.
。 Data were revealed 4 days ago for this therapy and it reached its primary endpoint
.
This year, WuXi AppTec's content team will continue to monitor the progress of
these investigational therapies.
We also wish these therapies good results for the benefit of patients around the world!
The pictures in this article are based
on reference materials [1], as well as clinical trial registration information.
on reference materials [1], as well as clinical trial registration information.
Resources:
Resources:
[1] Evaluate Vantage 2023 Preview.
Retrieved December 14, 2022, from
Retrieved December 14, 2022, from [2] Pfizer Announces Positive Top-Line Results from Phase 3 Study of Hemophilia B Gene Therapy Candidate, Retrieved December 31, 2022, from [2] Pfizer Announces Positive Top-Line Results from Phase 3 Study of Hemophilia B Gene Therapy Candidate, Retrieved December 31, 2022, from
