ASCO annual meeting grand opening!

Transfer from Pharmaceutical Mission Hills

On June 4th, US Eastern Time, the annual American Society of Clinical Oncology (ASCO) annual meeting was grandly opened.

Earlier, we have sorted out some research topics, research abstracts, and major research abstracts that were successfully selected into the plenary conference for readers.

1.

Indications: Advanced solid tumor with abnormal FGFR gene

ICP-192 (gunagratinib) is a new and highly selective pan-FGFR (fibroblast growth factor receptor) inhibitor independently developed by Nuocheng Jianhua.

At this conference, the Phase 1 clinical results of ICP-192 for patients with advanced solid tumors with abnormal FGFR genes will be released.

2.

Indications: advanced solid tumor

MVR-T3011 is the first new generation of recombinant herpes oncolytic virus independently developed by Innomicro.

At this conference, Innomicropharmaceuticals will announce the results of Phase 1 of the MVR-T3011 product for the first time in a poster.

3.

Indications: postoperative adjuvant treatment of lung adenocarcinoma, kidney cancer

Icotinib: is a potent and highly selective oral EGFR-TKI.

Studies have shown that compared to the 1-year targeted therapy group with icotinib (referred to as the "1-year group"), the 2-year targeted therapy with icotinib (referred to as the "2-year group") significantly improved the patient's disease-free survival ( DFS, 48.

Voronib: It is a new generation of multi-target kinase inhibitor with a new chemical structure.

The results of the study showed that as of April 30, 2020, the progression-free survival (PFS) of the voronib+everolimus combination treatment group was longer than that of the everolimus single-agent group (median PFS, 10.

4.
Deci Pharmaceuticals: Celiniso

Mechanism of action: XPO1 inhibitor

Indications: multiple myeloma

Celiniso (ATG-010) is an oral selective nuclear export inhibitor compound developed by Karyopharm Therapeutics.
Deqi Pharmaceuticals has a large number of drugs in Greater China, South Korea, Australia, New Zealand and ASEAN countries.
Exclusive development and commercialization rights in the Asia-Pacific market.
At this conference, Deqi Pharmaceuticals will announce the latest research results of the Phase 2 MARCH trial of Celinisol combined with dexamethasone (Sd regimen) in the treatment of Chinese patients with relapsed and refractory multiple myeloma.

The data showed that the planned analysis for the first 60 patients receiving treatment, the median follow-up time was 9.
5 months, and the ORR was 26.
7%.
In addition, the test results showed that the ORR of Sd regimen was 33.
3% in patients exposed to three types of drugs (immunomodulators, proteasome inhibitors and CD38 monoclonal antibodies), and the ORR reached 44.
4 in patients who had previously received CAR-T therapy.
%.
Among Chinese multiple myeloma patients who have received immunomodulators and proteasome inhibitors and still relapse, the MARCH trial data is consistent with the STORM trial (the trial data once supported the FDA to accelerate the approval of Celiniso), which further proves that Sd The effectiveness and safety of the program.

5.
BeiGene: Tilelizumab

Mechanism of action: PD-1 inhibitor

Indications: esophageal squamous cell carcinoma, rectal cancer, etc.

Tilelizumab is a humanized lgG4 anti-programmed death receptor 1 (PD-1) monoclonal antibody designed to minimize binding to Fcγ receptors in macrophages.
At this conference, the data of the global phase 3 clinical study RATIONALE 302 and phase 2 clinical study RATIONALE 209 of tislelizumab were officially announced.

According to reports, the RATIONALE 302 study is a randomized, open, multi-center, global phase 3 clinical trial designed to evaluate tislelizumab versus chemotherapy selected by investigators as the second-line treatment for patients with advanced or metastatic esophageal squamous cell carcinoma Effectiveness and safety.
The data showed that the primary endpoint of the study-the median overall survival of the intention-to-treat (ITT) population was 8.
6 months, reducing the risk of death by more than 30%, and the ORR was 20.
3%.
The results of the study show that tislelizumab is more effective than chemotherapy in the second-line monotherapy of esophageal squamous cell carcinoma, which brings good OS benefits to patients.

RATIONALE 209 is a phase 2 clinical study designed to evaluate tislelizumab as a single-agent treatment of previously treated, locally advanced unresectable or metastatic microsatellite highly unstable (MSI-H)/mismatch repair defect (dMMR) ) The effect of patients with solid tumors.
According to reports, the study focused on colorectal cancer, with an overall ORR of 45.
9%.

In addition, the long-term follow-up effectiveness and safety results of the key phase 2 clinical trial of tislelizumab for the treatment of patients with relapsed/refractory classic Hodgkin's lymphoma were also announced at this annual meeting.
It is reported that BeiGene is also extensively exploring the therapeutic combination of immune combination therapy, and announced the clinical trial design and results of three of the drug combinations at this ASCO annual meeting, including tislelizumab combined with an anti-TIGIT under study Antibody ociperlimab, tislelizumab combined with chemotherapy, and tislelizumab combined with the research anti-HER2 bispecific antibody zanidatamab (ZW25) authorized by Zymeworks.

6.
Corning Jerry: KN046

Mechanism of action: PD-L1/CTLA-4 bispecific antibody

Indications: Combination chemotherapy for first-line treatment of pancreatic cancer

KN046 is a PD-L1/CTLA-4 bispecific antibody developed by Corning Jereh.
It is composed of CTLA-4 and PD-L1 single domain antibodies with different mechanisms, which can be targeted and enriched in PD-L1 highly expressed Tumor microenvironment and elimination of Treg that inhibit tumor immunity.
KN046 has carried out nearly 20 clinical trials in different stages covering more than 10 types of tumors including non-small cell lung cancer, triple negative breast cancer, esophageal squamous cell carcinoma, thymic cancer, liver cancer, and pancreatic cancer.

Corning Jerry announced today (June 5) that its KN046 combined with albumin paclitaxel/gemcitabine first-line treatment of pancreatic ductal adenocarcinoma (PDAC) phase 2 clinical study data (study number: KN046-IST-04), in the form of a poster Announced at the 2021 ASCO Annual Meeting.
As of January 15, 2021, 9 patients received at least one tumor assessment and entered the efficacy analysis data set, and 17 patients entered the safety analysis data set.
The objective response rate (ORR) was 55.
6%, and the disease control rate (DCR) was 88.
9%.
The Phase 3 clinical study of KN046 combined with chemotherapy for the first-line treatment of pancreatic cancer will start in 2021.

7.
Cinda Bio: IBI110

Mechanism of action: anti-LAG-3 monoclonal antibody

Indications: advanced solid tumor

IBI110 is an anti-LAG-3 monoclonal antibody.
LAG-3 (CD223) is a potential tumor immunotherapy target because it has a negative regulatory effect on T cells, and works with PD-1 to mediate the state of cell failure.
On June 5th, Innovent announced that it will announce the results of the phase 1a/1b clinical study of IBI110 in the form of a poster at the 2021 ASCO annual meeting.
This is a phase 1 clinical study evaluating the safety, tolerability and effectiveness of IBI110 single-agent and combined sintilimab in the treatment of subjects with advanced malignancies.
As of February 9, 2021, a total of 40 patients with advanced solid tumors who failed standard treatment were enrolled in the study.

Among them, a total of 7 dose groups were set up for phase 1a IBI110, and 22 subjects were enrolled.
All preset climbing doses have been completed.
No dose-limiting toxicity occurred, and there were no adverse effects that caused the discontinuation of the trial drug or caused death.
event.
In terms of curative effect, a patient with advanced ovarian cancer who progressed after receiving multi-line systemic treatment achieved partial remission after receiving IBI110 monotherapy and continued monotherapy for more than 6 months.

In the phase 1b combined with sintilimab dose ramp-up phase, IBI110 has 5 dose groups and 18 subjects were enrolled.
All preset ramp-up doses have been completed, no dose-limiting toxicity occurred, and no trial was caused.
Drug withdrawal or adverse events leading to death.
As of April 26, 2021, 3 subjects had achieved partial remission, with an initial objective effective rate of 16.
7%, which demonstrated the synergistic anti-tumor effect of the combination therapy.

ASCO annual meeting is one of the most authoritative academic exchange events in the field of oncology in the world.
The 2021 ASCO annual meeting will continue until June 8.
We will continue to follow the development of the conference, and look forward to hearing more of the latest research progress, and sharing more good news in the frontier research field of cancer.

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