Chinese Pharma Shines at ESMO 2023: Hengrui, BeiGene Among 17 Companies Presenting Oral Reports

From October 20 to 24, the 2023 European Society for Medical Oncology (ESMO) Annual Meeting is being held in Madrid, Spain.

As the annual "benchmark event" in the European oncology community,ESMO is one of the most influential medical conferences globally and serves as a significant platform for the release of research data on highly anticipated products from major pharmaceutical companies, as well as important clinical trial results.Many multinational pharmaceutical companies such as Johnson & Johnson, AstraZeneca, Seagen, Daiichi - Sankyo, and Novartis showcased their innovation capabilities, while Chinese innovative pharmaceutical companies are also making their mark.

Oral presentations have always been the highlight of tumor academic conferences. According to incomplete statistics,Hengrui Medicine, Innovent Biologics, BeiGene, Hutchmed, Ascentage Pharma, Kelun-Biotech, JACOBIO, and 17 other Chinese pharmaceutical companiesThe latest research results will be presented orally at this year's ESMO Annual Meeting. In addition, several pharmaceutical companies have multiple projects selected for poster presentations/ongoing trials.

From the perspective of the R&D pipeline, PD-1 remains the most mainstream cancer research target. Hengrui, Beigene, and Junshi’s LBA selections all include their self-developed PD-1 drugs. Innovative pharmaceutical companies such as Yifang Biotech and JACOBIO are focusing on emerging targets like TIGHT and KRAS G12C. Meanwhile, Akeso Biopharma, Alphamab Oncology, Kelun-Biotech, and Mabwell have announced advances in new drug development related to next-generation biotechnology platforms such as bispecific antibodies and ADCs.

More details about the 2023 ESMO Congress are organized by Jian Shi Ju as follows:

October 21,Hengrui Medicine Announces Phase III Randomized Controlled Trial Data of PD-1 Camrelizumab in Combination with Apatinib ("Double-A" Regimen) and Chemotherapy versus Chemotherapy for Locally Advanced Gastric Cancer.

Professor Li Chen from Ruijin Hospital, affiliated with the Shanghai Jiao Tong University School of Medicine, announced the relevant data of this groundbreaking study at the event. This study is the world's first Phase III trial on the combination of targeted therapy and immunotherapy in the perioperative period for gastric cancer. The results showed,The pathological complete response (pCR) rate was 18.3% in the camrelizumab plus apatinib and chemotherapy group, significantly higher than 5.0% in the chemotherapy group, reaching the primary endpoint.

Another study included in the oral presentation was the "Phase III Randomized Controlled Trial of Neoadjuvant Short-Course Radiotherapy Sequential with Camrelizumab Combined with Chemotherapy versus Long-Course Chemoradiotherapy Sequential with Chemotherapy for Locally Advanced Rectal Cancer (UNION)" led by Professor Zhang Tao and Professor Tao Kaixiong from Union Hospital, Tongji Medical College, Huazhong University of Science and Technology.

It is worth mentioning that Hengrui Medicine once again strongly covered more than ten tumor fields, including gastrointestinal cancer, breast cancer, cervical cancer, and pancreatic cancer. A total of 36 research achievements from 13 innovative anti-tumor drugs were selected, with 8 studies chosen for oral/short oral presentations and 28 studies accepted as posters.

Junshi Biosciences presented at this year's ESMO Congress in the form of a preferred oral report,Data results from two studies on the anti-PD-1 monoclonal antibody Toripalimab have been released: a pivotal Phase 3 clinical trial for the treatment of advanced renal cell carcinoma, and a Phase 2 clinical trial for the treatment of extranodal NK/T-cell lymphoma (ENKTL).

Among them, in the trial comparing toripalimab combined with tyrosine kinase inhibitor (TKI) axitinib versus TKI sunitinib as first-line treatment for intermediate- to high-risk unresectable or metastatic renal cell carcinoma (RCC), the toripalimab plus axitinib group showed a significantly prolonged PFS compared to the control group receiving monotherapy (median PFS of 18.0 vs. 9.8 months), reducing the risk of disease progression or death by 35% (1-year PFS rate was 62.7% vs. 45.4%).

In addition to the two oral presentations mentioned above, Junshi Biosciences presented several research results in the form of posters at this year's ESMO Congress.Including the Phase 1a first-in-human study of JS007 (a novel anti-CTLA-4 monoclonal antibody) for advanced solid tumors,And the clinical research results of various immunotherapy combination regimens, covering both early and advanced cancer patients.

At this conference,Two Phase 3 studies of BeiGene's PD-1 inhibitor tislelizumab for the treatment of advanced gastric or gastroesophageal junction (G/GEJ) adenocarcinoma and non-small cell lung cancer (NSCLC),Selected for the Latest Breakthrough Abstract (LBA) at the Annual Meeting.

Latest data shows that among patients with resectable non-small cell lung cancer (NSCLC) who received tislelizumab combined with chemotherapy before surgery, 56.2% achieved major pathological response, compared to 15.0% in patients receiving neoadjuvant chemotherapy alone. Analysis found that among patients treated with a tislelizumab-containing regimen, 40.7% reached the key secondary endpoint of pathological complete response, compared to 5.7% in those receiving neoadjuvant chemotherapy alone.

Compared with neoadjuvant chemotherapy alone, the addition of tislelizumab to platinum-based neoadjuvant chemotherapy followed by adjuvant tislelizumab monotherapy demonstrated a statistically significant improvement in event-free survival.

In addition, in the first-line treatment of patients with advanced gastric or gastroesophageal junction adenocarcinoma (GC/GEJC),The median overall survival for tislelizumab combined with chemotherapy as a first-line treatment was 15.0 months, compared to 12.9 months for placebo combined with chemotherapy.Tislelizumab in combination with chemotherapy significantly improved overall survival (OS) in the intent-to-treat (ITT) population, with no new safety signals identified.

In the KRAS and SHP2 inhibitor fields, JACOBIO, a leading Chinese innovative pharmaceutical company with relatively advanced R&D progress, also made an appearance at this conference.Oral Presentation to Announce Combination Data of Two Major Targeted Drugs: Gleciras (KRAS G12C Inhibitor) and JAB-3312 (SHP2 Inhibitor).

Data show that among 129 patients with non-small cell lung cancer, 107 patients underwent at least one tumor assessment according to RECIST 1.1 criteria. Among the 87 patients who had not been treated with a KRAS G12C inhibitor, 58 were first-line treatment patients (including seven dose groups). The ORR was 65.5% (38/58), and the DCR was 100%.

In the Glelares registration trial dose of 800 mg (monotherapy registration trial dose) and the combination dose group with 2 mg JAB-3312, the ORR (Objective Response Rate) was 86.7% (13/15), DCR 100%. Compared to Glelares monotherapy, the objective response rate significantly increased.

JACOBIO is the second company globally to advance SHP2 into clinical trials. In the clinical trial of the combination therapy of SHP2 inhibitors and KRAS G12C inhibitors, JACOBIO is expected to become the first company to bring an SHP2 inhibitor to market.

On October 23, Yifang Biotech presented a poster at the conference disclosing the early clinical study data of Garsorasib (D-1553) in patients with advanced pancreatic cancer (PCa) harboring KRAS G12C mutations.

Garsorasib is a novel, highly efficient KRAS G12C selective inhibitor independently developed by Innovent Biologics.This is also the first time that Innovent Biologics has disclosed the safety and efficacy data of Garsorasib in PCa patients with KRAS G12C mutations.

The results showed that Garsorasib monotherapy demonstrated good tolerability and clinical activity in patients with KRAS G12C-mutated PCa, with a confirmed objective response rate (ORR) of 35.7% (5/14), a disease control rate (DCR) of 85.7% (12/14), and a median progression-free survival of 8.54 months (95% CI, 2.73, NA).

At this year's ESMO Congress, Hansoh announced a randomized multicenter study aimed at comparing the efficacy of Aumolertinib + Apatinib versus Aumolertinib monotherapy as first-line treatment for patients with EGFR mutation-positive locally advanced or metastatic non-small cell lung cancer (NSCLC).

The research results show,The overall ORR for the Armnetinib + Apatinib group and the Armnetinib group were 72.9% and 64%, respectively.DCR was 100% and 94%, respectively; in the EGFR-sensitive mutation (19del or L858R) subgroup, the ORR for the Aumolertinib + Apatinib group and the Aumolertinib group was 75% and 68%, respectively.

Ameitinib, a third-generation epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) developed by Hansoh Pharma, was approved in December 2021 for first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have exon 19 deletions or exon 21 (L858R) substitution mutations in the epidermal growth factor receptor (EGFR).

Currently, the standard first-line treatment for patients with locally advanced or metastatic EGFR-mutated NSCLC is the use of third-generation EGFR-TKI alone, which has certain limitations in efficacy. Due to synergistic effects, the combination of EGFR-TKI with small-molecule anti-angiogenic agents may be a potential solution.

At the conference, Professor Zhang Li from the Sun Yat-sen University Cancer Center orally presented China's first domestically produced innovative drug as the reporter.Updated Data from Phase I Clinical Study of EGFR x HER3 Bispecific Antibody-Drug Conjugate (ADC) BL-B01D1 in Non-Small Cell Lung Cancer (NSCLC).

Data showed that the median Duration of Response (DoR) was 8.5 months (95% CI: 2.8-NR) for EGFR-mutant NSCLC patients and not reached (95% CI: 5.6-NR) for EGFR wild-type NSCLC patients, while the median PFS was 5.6 months (95% CI: 3.9-9.7) and 5.4 months (95% CI: 4.0-6.8), respectively.

It is reported that BL-B01D1, developed by Baili Tianheng, uses a bispecific antibody (SI-B001) that simultaneously targets EGFR and HER3 in its design. It is linked to an innovative topoisomerase I inhibitor (Ed-04) at a ratio of 1:8 using a more stable degradable linker. In xenograft mouse models composed of human tumor cells,The bispecific ADC BL-B01D1 demonstrated stronger anti-tumor effects compared to EGFR-ADC and HER3-ADC.

Since HER3 was discovered more than 30 years ago in 1989, HER3-targeted therapies entered clinical trials in 2008, yet no HER3-targeted therapy has been approved for marketing to date.

At the conference, Mabwell announced the latest progress in two clinical studies, including the innovative Nectin-4-targeted ADC drug 9MW2821.

9MW2821 is the first ADC new drug developed by Mabwell Biotherapeutics that targets Nectin-4, and it is the first drug of its kind in China to enter clinical trials.Core data show: In the Phase I/II clinical study, among 39 evaluable solid tumor subjects treated with 1.25mg/kg or higher doses of 9MW2821, the ORR and DCR were 38.5% and 84.6%, respectively. Among 18 evaluable urothelial cancer subjects in the 1.25mg/kg dose group, the ORR and DCR were 55.6% and 94.4%, respectively.

The world's first Nectin-4 ADC new drug, Padcev, was approved for marketing in Japan and the United States in 2019 and 2021 respectively, with global sales of Padcev reaching nearly $800 million in 2022.

In addition to 9MW2821, Mabwell also announced the Phase III clinical research data of 8MW0511 at the conference and stated that it is expected to file an NDA within the year.8MW0511 is an injectable recombinant (yeast-secreted) human serum albumin-human granulocyte colony-stimulating factor fusion protein.Belongs to Category 1 of therapeutic biological products.