 Home > Active Ingredient News > Drugs Articles > 15 innovative drugs have reached the primary endpoint in Phase 3 clinical trials, from companies such as AbbVie, Merck, AstraZeneca, Hengrui Pharmaceuticals, etc.!

15 innovative drugs have reached the primary endpoint in Phase 3 clinical trials, from companies such as AbbVie, Merck, AstraZeneca, Hengrui Pharmaceuticals, etc.!

 Last Update: 2021-12-07
 Source: Internet
 Author: User

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According to public information, in October this year (October 1st to October 31st), another batch of innovative drugs around the world reached the main research endpoint in phase 3 clinical trials
.

Phase 3 clinical trials are a particularly important and critical link in the development of new drugs: for new drugs under development, its success often indicates that the drug can be submitted for marketing applications soon; for new drugs that have been approved, new clinical success means them It is expected to usher in new indications

1.
AbbVie: ABBV-951 drug ingredient: prodrug of levodopa and carbidopa Indication: Parkinson's disease

Since the 1970s, the main treatment for patients with Parkinson's disease has been levodopa
.

ABBV -951 developed by AbbVie is a prodrug of levodopa and carbidopa .

ABBV-951 is a prodrug of levodopa and carbidopa

On October 28, AbbVie announced that ABBV-951 had reached the primary endpoint in a pivotal Phase 3 clinical trial
.

The test results showed that compared with oral levodopa/carbidopa (levodopa/carbidopa), subcutaneous infusion of ABBV-951 for 24 hours a day significantly improved the fluctuation of motor symptoms in patients with advanced Parkinson's disease

ABBV-951 may become a potential alternative treatment option for patients with advanced Parkinson's disease

2.
Hengrui Medicine: Adbelizumab (SHR-1316) Mechanism of Action: Anti-PD-L1 mAb Indication: First-line treatment of extensive-stage small cell lung cancer

2.
Hengrui Medicine: Adbelizumab (SHR-1316) Mechanism of Action: Anti-PD-L1 monoclonal antibody Indications: First-line treatment of extensive-stage small cell lung cancer First-line treatment of extensive-stage small cell lung cancer

Adbelizumab is a humanized anti-PD-L1 monoclonal antibody independently developed by Hengrui Medicine
.

On October 27, Hengrui Medicine announced that Adbelizumab combined with chemotherapy has reached the primary research endpoint in the Phase 3 clinical study of the first-line treatment of extensive-stage small cell lung cancer

Adbelizumab combined with chemotherapy for first-line treatment of extensive-stage small cell lung cancer achieves significant and clinically significant prolongation of overall survival (OS)

3.
Merck: islatravir/doravirine combination therapy Mechanism of action: NRTTI/NNRTIs indication: AIDS

Islatravir is an innovative nucleoside reverse transcriptase translocation inhibitor (NRTTI), which can inhibit the function of HIV reverse transcriptase through a variety of mechanisms
.

Doravirine is a once-a-day oral innovative non-nucleoside reverse transcriptase inhibitor (NNRTIs) developed by Merck (MSD).

October 25, Merck announced that combination therapy with doravirine islatravir constituted , two pivotal Phase 3 trials conducted in HIV-1 infected adult patients reached the study endpoint
.

These patients obtained virological suppression after receiving different antiretroviral therapy (ART) or a combination of common AIDS drugs bictegrair/emtricitabine/tenofovir (BIC/FTC/TAF)

The combination therapy consisting of islatravir and doravirine reached the study endpoint in two pivotal phase 3 trials in adult patients with HIV-1 infection

4, AstraZeneca: degree cutting Li You mAb (durvalumab) mechanism of action: the PD-Ll inhibitor indications: the first-line treatment of advanced biliary tract cancer

4, AstraZeneca: degree cutting Li You mAb (durvalumab) of cutting Li You mAb (durvalumab) (durvalumab) Mechanism: PD-L1 inhibitor PD-L1 inhibitor indications: the first-line treatment of advanced biliary tract cancer line treatment Advanced biliary tract cancer

On October 25, AstraZeneca announced that duvalizumab combined with chemotherapy has reached the primary endpoint in a phase 3 clinical trial of first-line treatment of patients with advanced biliary tract cancer
.

The results of the trial showed that compared with chemotherapy alone, the duvalizumab combination provided patients with a statistically significant and clinically significant overall survival (OS) benefit

Duvalizumab combined with chemotherapy in the first-line treatment of patients with advanced biliary tract cancer

On October 22, Regeneron and Sanofi announced that Duplizumab injection has reached a critical phase 3 clinical trial for the treatment of adult patients with poorly controlled prurigo nodularis.
Primary and all critical secondary endpoints
.
The test results showed that compared with placebo, Duplizumab significantly reduced the symptoms of itching and skin lesions in patients
.
On October 25, the two companies announced again that Duplizumab had reached the dual primary endpoint in the second clinical trial for the treatment of eosinophilic esophagitis
.
Compared with placebo, Duplizumab significantly improved patients' clinical symptoms and histological disease indicators
.

Treatment of adult patients with poorly controlled prurigo nodularis significantly reduces pruritus symptoms and skin lesions in patients with eosinophilic esophagitis

6.
LEO Pharma: tralokinumab Mechanism of action: IL-13 monoclonal antibody Indication: Adolescent patients with atopic dermatitis

Atopic dermatitis is a chronic inflammatory skin disease.
Type 2 cytokines including IL-4 and IL-13 are the key factors driving the pathology of atopic dermatitis
.
Due to the immune system dysregulation, IL-13 is overexpressed in the skin of patients
.
Tralokinumab is a high-affinity human IL-13 monoclonal antibody that specifically binds and inhibits IL-13
.
It was approved by the European Union in June this year and was the first IL-13 monoclonal antibody approved
.

Is the first IL-13 monoclonal antibody approved

On October 22, LEO Pharma announced that tralokinumab had obtained positive results in a phase 3 clinical trial for the treatment of atopic dermatitis in adolescent patients (12-17 years old)
.
Experimental data showed that the study reached its primary and secondary endpoints
.
Compared with placebo, the two doses (150 mg/300 mg) of tralokinumab significantly improved the patient's efficacy indicators, and the drug was well tolerated
.

Treatment of atopic dermatitis in adolescent patients (12-17 years old)

7.
Menarini Group and Radius Health: elacestrant mechanism of action: selective estrogen receptor degrading agent (SERD) indication: breast cancer

Estrogen receptor positive, HER2 negative (ER+/HER2-) is the most common form of breast cancer
.
Elacestrant is an oral selective estrogen receptor degrading agent that has the potential to be used as a monotherapy or a member of combination therapy to treat breast cancer
.
On October 20th, Menarini Group and Radius Health announced that elacestrant had reached two primary endpoints in a phase 3 clinical trial
.

This phase 3 clinical trial aims to evaluate the efficacy of elacestrant as a single agent in the treatment of ER+/HER2- advanced or metastatic breast cancer patients compared with standard treatments.
The trial enrolled 466 patients who had previously received first-line or second-line endocrine therapy, including CDK4/6 Patients treated with inhibitors
.
The results of the study showed that the treatment group showed a statistically significant improvement in terms of the two primary endpoints of progression-free survival (PFS) and PFS of patients with estrogen receptor 1 (ESR1) mutation tumors
.

Subjects Progression-free survival (PFS) PFS in patients with tumors with estrogen receptor 1 (ESR1) mutations

8.
ImmunityBio: Anktiva (N-803) Mechanism of action: IL-15 super agonist Indication: Non-muscle invasive bladder cancer

The cytokine interleukin-15 (IL-15) plays a vital role in the immune system by affecting the development, maintenance and function of natural killer (NK) cells and immune T cells
.
Anktiva consists of IL-15 mutant (IL-15N72D) that binds to IL-15 receptor α/IgG1 Fc fusion protein
.
It binds to βγ T cell receptors, directly and specifically stimulates CD8 positive T cells and NK cells, while avoiding stimulation of regulatory T cells (Treg)
.

On October 19th, ImmunityBio announced that the combination of Anktiva and Bacille Calmette-Guerin (BCG) has achieved the treatment of papilloma in a Phase 2/3 clinical trial for the treatment of non-muscular invasive bladder cancer (NMIBC) that does not respond well to BCG .
The primary endpoint for patients with subtypes
.
The results of the test showed that: 57% of patients achieved a disease-free survival (DFS) of 12 months
.

Treatment of non-muscular invasive bladder cancer (NMIBC) that does not respond well to BCG vaccine 57% of patients achieve a disease-free survival (DFS) of 12 months

9.
Zai Lab, Entasis: sulbactam-durlobactam (SUL-DUR) Mechanism of action: antibiotic combination therapy Indication: patients with carbapenem-resistant Acinetobacter (CRAB)

Acinetobacter is a Gram-negative bacterium and is considered a serious global public health threat
.
Sulbactam (sulbactam) is an intravenous infusion of β-lactam antibiotics, durlobactam is a new broad-spectrum intravenous infusion of β-lactamase inhibitors, they are combined with Acinetobacter organisms (including Carbapenem resistant strains) have unique activities
.
Zai Lab owns the development and commercialization of SUL-DUR in Greater China (Mainland China, Hong Kong, Macau, Taiwan), South Korea, Vietnam, Thailand, Cambodia, Laos, Malaysia, Indonesia, Philippines, Singapore, Australia, New Zealand and Japan Exclusive authorization
.

Their combined use has unique activity against Acinetobacter organisms (including carbapenem resistant strains)

On October 19, Zai Lab and Entasis announced that the antibiotic combination therapy SUL-DUR has obtained a positive key result in a global phase 3 registered clinical study called ATTACK
.
In patients with carbapenem-resistant Acinetobacter, compared with polymyxin, SUL-DUR treatment reached the primary endpoint of 28-day all-cause mortality
.
In terms of cure evaluation, compared with polymyxin, the SUL-DUR treatment group has a better response to treatment, and there is a statistically significant difference
.
In addition, SUL-DUR also has better safety
.
According to the press release, SUL-DUR plans to submit a New Drug Application (NDA) in mid-2022
.

SUL-DUR treatment reached the primary endpoint of 28-day all-cause mortality

10.
Phathom Pharmaceuticals: Vonolasen Mechanism of Action: P-CAB Indications: erosive esophagitis, heartburn

Vonoprazan is a new potassium ion competitive acid blocker (P-CAB) , which can competitively block the combination of potassium ion and hydrogen/potassium ion ATPase, thereby quickly inhibiting the secretion of gastric acid
.
Because of its long half-life and longer duration of action, Vonola is regarded as an effective long-acting proton pump inhibitor (PPI)
.

A new type of potassium ion competitive acid blocker (P-CAB)

On October 18, Phathom Pharmaceuticals announced that Vonolasen had reached the primary endpoint and critical secondary endpoint in a pivotal Phase 3 clinical trial
.
The results of the test showed that compared with the active control, Vonolasan showed a better healing maintenance effect in all patients with erosive esophagitis (week 24), and the healing rate was better in the treatment of moderate/severe patients (second Weeks)
.
Phathom plans to submit a new drug listing application for Vonolasen to the US FDA for the treatment of "healing maintenance and heartburn relief of all grades of erosive esophagitis"
.
It is worth mentioning that Vonolasan has been approved in China for the treatment of reflux esophagitis and maintenance treatment of reflux esophagitis
.

Vonolasan showed better healing and maintenance effects in all patients with erosive esophagitis (week 24), and the healing rate of moderate/severe patients was better (week 2) for the treatment of "all grades of erosions" Healing maintenance and heartburn relief of esophagitis"

11.
Xinda Bio: Sintilimab Mechanism of Action: PD-1 Inhibitor Indication: Non-small cell lung cancer (NSCLC)

11, the letter bio: channels Dealy Mab channel Piccadilly monoclonal Mechanism: PD-1 inhibitors indications: non-small cell lung cancer (NSCLC) non-small cell lung cancer (NSCLC)

Sintilimab is an innovative PD-1 inhibitor that has been approved in China for the treatment of specific classic Hodgkin's lymphoma, EGFR or ALK-negative advanced non-squamous NSCLC, squamous NSCLC, and hepatocellular carcinoma
.
Currently, Sintilimab has more than 20 clinical studies in progress
.

On October 18th, Cinda Bio announced that the combination of Sintilizumab and Dyutone (bevacizumab biosimilar) and chemotherapy have reached the primary study endpoint in the first interim analysis of a phase 3 clinical trial
.
The indications for this study are: EGFR-mutant non-squamous NSCLC patients who have received epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) treatment failure
.
The results of the study showed that compared with chemotherapy, sintilimab combined with davidone and chemotherapy achieved a significant and clinically significant progression-free survival prolongation, reaching the preset superiority standard
.

Sintilizumab combined with davidone and chemotherapy achieved a significant and clinically significant progression-free survival prolongation, reaching the preset superiority standard

12.
AstraZeneca: Imfinzi+tremelimumab Mechanism of action: anti-PD-L1 antibody, anti-CTLA-4 antibody Indication: first-line treatment of hepatocellular carcinoma

Imfinzi is an anti-PD-L1 monoclonal antibody
.
Tremelimumab is an anti-CTLA-4 antibody
.
On October 16, AstraZeneca announced that the combination of Imfinzi and tremelimumab had reached the primary endpoint in a phase 3 clinical trial for the first-line treatment of unresectable hepatocellular carcinoma
.
The test results show that compared with the active control, the overall survival of patients in the combination treatment group has a statistically significant difference and a clinically significant improvement
.
The press release pointed out that this is the first time that dual immunotherapy has significantly improved the overall survival of patients with liver cancer in the first-line treatment
.

First-line treatment for unresectable hepatocellular carcinoma.
This is the first time that dual immunotherapy can significantly improve the overall survival of patients when first-line treatment of liver cancer patients.

13.
AbbVie: Upadacitinib Mechanism of Action: JAK Inhibitor Indication: Axial Spondylitis (axSpA)

Upatinib is an oral, selective and reversible JAK inhibitor, previously approved for the treatment of adult patients with moderate to severe active rheumatoid arthritis
.
On October 7, AbbVie announced that two phase 3 clinical trials of upatinib in adult patients with axial spondylitis reached the primary endpoints
.
For the live patient mobility ankylosing spondylitis (the AS) .
3 in clinical, upa imatinib group 45% of patients meet international standards spondyloarthritis Association (ASAS) 40, and significantly better than the placebo group (18 %)
.
In another phase 3 clinical trial for patients with active non-radiological axial spondyloarthritis , 45% of patients in the upatinib group met the ASAS40 standard, which was also significantly higher than the placebo group (23%)
.

In axial spondylitis adult patients live movable ankylosing spondylitis (AS) patients with active non-radiological axis spine arthritis

14.
Bausch+Lomb Company: NOV03 Mechanism of Action : Eye drops with a unique mechanism of action Indications: Dry eye

Dry eye is one of the most common ocular surface disorders.
Meibomian gland dysfunction is the main reason for the development and progression of volatile dry eye
.
NOV03 (perfluorohexyl octane ophthalmic solution) is a potential "first-in-class" eye drops therapy under research, with a unique mechanism of action
.
It does not contain water and preservatives, and can stabilize the lipid layer in the tear film and reduce the excessive volatilization of tears
.

On October 1, Bausch+Lomb announced that NOV03 has reached all primary and secondary endpoints in the second phase 3 clinical trial for the treatment of dry eye related to meibomian gland dysfunction
.
Compared with the control group, the total corneal fluorescein staining (tCFS) index for evaluating eye damage showed a statistically significant improvement on the 57th day of treatment
.
At the same time, compared with the control group, the change in dry eye score was also statistically significantly improved on the 57th day
.
In addition, the trial reached all secondary endpoints
.
Based on these data, Bausch+Lomb plans to submit a new drug marketing application to the FDA in 2022
.
It is worth mentioning that Hengrui Medicine has the development rights of this innovative therapy in China
.

In the treatment of dry eye related to meibomian gland dysfunction, Hengrui Medicine has the development rights of this innovative treatment in China

15.
Sanofi: Mechanism of action of iGlarLixi : a compound preparation of basal insulin and GLP-1RA Indication: Diabetic patients

15.
Sanofi: iGlarLixi iGlarLixi mechanism of action: a compound preparation of basal insulin and GLP-1RA Indication: diabetic patients

iGlarLixi is a compound preparation of basal insulin and glucagon-like peptide-1 receptor agonist (GLP-1RA), which is composed of 100U/mL insulin glargine and risnatide in a fixed ratio
.
Sanofi China announced at the 57th European Association for the Study of Diabetes (EASD) Annual Meeting that iGlarLixi reached the primary efficacy endpoint and secondary endpoint in the China study of the phase 3 clinical trial LixiLan-L
.

The results of the study showed that compared with the basal insulin treatment group , patients treated with iGlarLixi reached the preset primary efficacy endpoint in reducing glycosylated hemoglobin (HbA1c)
.
At 30 weeks of treatment, the average HbA1c of patients in the iGlarLixi group was 6.
7%, while that in the basal insulin group was 7.
4%
.
In October 2021, the National Medical Products Administration (NMPA) of China has accepted the listing application of iGlarLixi
.

, The patients treated with iGlarLixi reached the preset primary efficacy endpoint in reducing glycosylated hemoglobin (HbA1c)

Congratulations to these innovative drugs for reaching the main research endpoints in phase 3 clinical trials, and hope that their follow-up studies will proceed smoothly and benefit the majority of patients as soon as possible
.

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