Esophageal Squamous Cell Carcinoma

SHANGHAI, March 19, 2024 /PRNewswire/ -- Mabwell (688062.SH), an innovative-driven biopharmaceutical company with entire industry chain, presented the clinical study data of the 9MW2821 for patients with cervical cancer as focused plenary oral presentation at the Society of Gynecologic Oncology (SGO) annual meeting on March 16, 2024. The data showed good efficacy and safety of 9MW2821 in patients with cervical cancer, which is expected to bring new breakthroughs for the treatment of recurrent or metastatic cervical cancer, meeting a large number of unmet clinical needs. 9MW2821 is the first drug to report clinical data for the indication of cervical cancer among the drugs with the same target in the world. Report on Study Data of Nectin-4-Targeting Antibody-drug Conjugate ( ADC ) for the Treatment of Recurrent or Metastatic Cervical Cancer This phase I/II, multicenter, open-label, clinical study was led by Professor Zhang Jian of Fudan University Shanghai Cancer Center, and Professor Yang Huijuan of Fudan University Shanghai Cancer Center represented the study team to give an in-depth report at the meeting. The study results were highly recognized by experts on site. Further clinical study data are expected to provide more treatment options for patients with recurrent or metastatic cervical cancer. Clinical Findings The systemic treatment drug options and efficacy for recurrent or metastatic cervical cancer are relatively limited. The cervical cancer cohort in the phase I/II study of 9MW2821 enrolled patients with Nectin-4-positive recurrent or metastatic cervical cancer who had progressed on or after doublet platinum-containing chemotherapy with or without bevacizumab and received no more than two previous systemic regimens for recurrent or metastatic disease. Eligible patients received intravenous 9MW2821 1.25mg/kg on days 1, 8 and 15 of each 28-day cycle until confirmed disease progression, death, intolerable adverse effects or withdrawal from the study. As of September 25, 2023, in the cervical cancer expansion cohort of the study, the detection rate of Nectin-4 expression was 89.67%, and the rate of Nectin-4 IHC 3+ was 67.82%. A total of 40 patients were enrolled in the study, 57.5% of the patients had previously received platinum-based doublet chemotherapy combined with bevacizumab, and 60% of the patients had previously received platinum-based doublet chemotherapy and immune checkpoint inhibitor therapy. In terms of efficacy, the overall response rate (ORR) and disease control rate (DCR) of 37 patients evaluable for efficacy were 40.54% and 89.19%, respectively, with one complete response (2.70%) and 14 partial responses (37.84%). Median progression-free survival (PFS), overall survival (OS), and duration of response (DOR) were not reached yet. Among patients with Nectin-4 IHC 3+, the ORR and DCR of 26 patients evaluable for efficacy were 50.00% and 92.31%, respectively. Among patients on or after doublet platinum-containing chemotherapy, the ORR and DCR of 21 patients evaluable for efficacy were 38.10% and 85.71%, respectively. In terms of safety, treatment-related adverse events (TRAEs) occurred in 92.50% of participants. Grade3-4 TRAEs occurred in 70.00% of participants, with neutropenia (40.00%), rash (17.50%) and gamma-glutamyl transferase increased (12.50%) being the most frequently reported. Nodeaths related to treatment were reported. The above study results indicate that 9MW2821 has controllable safety and positive efficacy in patients with cervical cancer. About 9MW2821 9MW2821 is the first site-specific conjugated novel ADC targeting Nectin-4 developed by Mabwell using ADC platform and automated high-throughput hybridoma antibody molecular discovery platform, and is the first product to enter clinical study among the products with the same target developed by Chinese companies. Multiple clinical studies of 9MW2821 have been conducted in China to evaluate the safety, tolerability, pharmacokinetic characteristics, and efficacy of 9MW2821 in patients with various advanced solid tumors. The phase III clinical study of 9MW2821 monotherapy has officially been initiated in patients with locally advanced or metastatic urothelial carcinoma who have previously received platinum-based chemotherapy and PD-(L)1 inhibitor therapy. The phase I/II clinical study of 9MW2821 in combination with PD-1 inhibitors is also ongoing, with the first patient already enrolled. The phase II clinical study for the indication of esophageal carcinoma will continue enrollment and evaluation, and communication for the initiation of phase III clinical study will be expedited. 9MW2821 was granted Fast Track Designation (FTD) by the U.S. Food and Drug Administration (FDA) in February 2024 for the treatment of advanced, recurrent, or metastatic esophageal squamous cell carcinoma. Currently, 9MW2821 is the first therapeutic drug targeting Nectin-4 in the world to disclose clinical efficacy and safety data for indications of cervical cancer and esophageal carcinoma. About Cervical Cancer Cervical cancer is the 4th most common neoplasm and the 4th leading cause of cancer death in females worldwide (excerpted from "Worldwide trends in cervical cancer incidence and mortality, with predictions for the next 15 years, Cancer 2021"). According to the "World Cancer Report 2020" released by the International Agency for Research on Cancer (IARC), there were 600 thousand new cases of cervical cancer worldwide in 2020 and up to 340 thousand deaths caused by cervical cancer. In February 2024, the National Cancer Center published the Cancer Burden Data in China in 2022 on Journal of the National Cancer Center (JNCC), showing that there were 150.7 thousand new cases of cervical cancer and 55.7 thousand deaths in China, ranking 8th and 9th respectively in terms of new cases and number of deaths. Compared with the 119 thousand new cases and 37 thousand deaths released in February 2022 for the same period in 2016, significant increases are observed. About Mabwell Mabwell (688062.SH) is an innovation-driven biopharmaceutical company with the entire value chain of the pharmaceutical industry. We provide more effective and accessible therapy and innovative medicines to fulfill global medical needs. Since 2017, an advanced R&D system which covers target discovery, early discovery, druggability, preclinical, clinical research and manufacturing transformation was established. Mabwell has 14 pipeline products in different stages based on a world-class and state-of-the-art R&D engine, including 10 novel drug candidates and 4 biosimilars. We focus on the therapeutic areas of oncology, auto-immune diseases, metabolic disorders, ophthalmologic diseases and infectious diseases, etc. Of these, 2 products have been approved and commercialized, 2 products have been filed for MA approval, 3 products are in pivotal trials. We have also undertaken 1 national major scientific and technological special project for "Significant New Drugs Development", 2 projects for National Key R&D Programmes, and multiple provincial and municipal science and technological innovation projects. Mabwell's Taizhou factory possesses robust in-house manufacturing capability compliant with international GMP standards regulated by the NMPA, FDA and EMA, and has passed the EU QP Audit. The large-scale manufacturing base located in Shanghai is under construction. Our mission is "Explore Life, Benefit Health" and our vision is "Innovation, from ideas to reality". For more information, please visit . Forward-Looking Statements This press release contains forward-looking statements including, but not limited to, the potential safety, efficacy, regulatory review or approval and commercial success of our product candidates and those relating to the Company's product development, clinical studies, clinical and regulatory milestones and timelines, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statements that are predictive in nature. "Forward-looking statements" are statements that are not historical facts and involve a number of risks and uncertainties, which may cause actual results to be materially different from any future results expressed or implied in the forward-looking statements. These statements may be identified by the use of forward-looking expressions, including, but not limited to, "expect," "anticipate," "intend," "plan," "believe," "estimate," "potential," "predict," "project," "should," "would," and similar expressions and the negatives of those terms. Forward-looking statements are based on the Company's current expectations and assumptions. Forward-looking statements are subject to a number of risks, uncertainties, and other factors, many of which are beyond the Company's control, including, but not limited to: environment; politic; economy; society; legislation; our dependence on our product candidates, most of which are still in preclinical or various stages of clinical development; our reliance on third-party vendors, such as contract research organizations and contract manufacturing organizations; the uncertainties inherent in clinical testing; our ability to complete required clinical trials for our product candidates and obtain approval from regulatory authorities for our product candidates; our ability to protect our intellectual property; the potential impact of COVID-19; the loss of any executive officers or key personnel. In case one or more of these risks or uncertainties deteriorate, or any assumptions are incorrect, the actual results may be seriously inconsistent with the stated results. The Company cautions all the persons not to place undue reliance on any such forward-looking statements, which speaks only as of the date of this press release. The Company disclaims any obligation, except as specifically required by law and the rules of the applicable Stock authority to publicly update or revise any such statements to reflect any change in expectations or in events, conditions, or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. All forward-looking descriptions, figures and assumptions in this press release are applicable to this statement. SOURCE Mabwell

BeiGene would have enjoyed Big Pharma support for Tevimbra from Novartis, but the two firms parted ways in September. Twenty months after the FDA’s original target decision date on cancer drug tislelizumab, BeiGene has finally received the U.S. go-ahead. The PD-1 inhibitor now carries the brand name Tevimbra. It’s approved to treat advanced esophageal squamous cell carcinoma after prior systemic chemotherapy, BeiGene said Thursday. Patients won’t be eligible for the drug if they have previously received a PD-1/L1 inhibitor. The FDA was originally scheduled to deliver a verdict on the drug in July 2022, but COVID-related travel restrictions disrupted that plan because the agency wasn’t able to perform preapproval inspections in China. Tevimbra secured its initial approval in China in December 2019 for previously treated classical Hodgkin lymphoma. Tevimbra isn’t the first PD-1 drug to reach esophageal cancer. Merck & Co.’s Keytruda and Bristol Myers Squibb’s Opdivo are both approved here. BeiGene would have enjoyed Big Pharma commercialization support for Tevimbra from Novartis, but the two firms parted ways in September, with Novartis citing a changing PD-1 inhibitor landscape as its rationale. Novartis will still help manufacture Tevimbra. Before the breakup, Novartis in 2022 decided not to file Tevimbra as a monotherapy for newly diagnosed non-small cell lung cancer (NSCLC) in the U.S. The decision came as the FDA cracked down on China-only data that didn’t reflect the treatment landscape in the U.S. Amid BeiGene’s regulatory delay, Coherus BioSciences and Junshi Biosciences-partnered Loqtorzi became the first China-made PD-1 inhibitor to reach the U.S. market with two indications in nasopharyngeal carcinoma. Tevimbra’s approval is based on the RATIONALE 302 trial, in which the BeiGene drug slashed the risk of death by 30% compared with chemotherapy. Patients on Tevimbra lived a median 8.6 months, versus 6.3 months for those who received traditional chemo. The European Commission in September approved Tevimbra for the same post-chemo esophageal cancer indication. BeiGene won’t launch Tevimbra immediately, saying it will make the drug available in the U.S. in the second half of 2024. The company also hasn’t launched the drug in Europe as it waits for a final European Commission approval for three NSCLC indications. The FDA is reviewing another Tevimbra application in first-line esophageal cancer, with a decision expected in July. A BeiGene spokesperson declined to comment on whether the company is holding off the rollout until the first-line decision. BeiGene will share Tevimbra’s price closer to launch, the spokesperson said. Coherus earlier this year launched Loqtorzi at a list price of $8,892.03 per single-use vial, which marks a 20% discount to Keytruda. “As BeiGene’s first drug candidate produced through our immuno-oncology program and second approved medicine in the U.S., Tevimbra is poised to be a critical pillar of our solid tumor development program,” Mark Lanasa, M.D. Ph.D., BeiGene’s chief medical officer of solid tumors, said in a statement Thursday. With multiple indications in China, Tevimbra grew sales by 27% year over year in 2023 to reach $537 million in 2023.

The FDA has granted approval to BeiGene's Tevimbra (tislelizumab-jsgr), for treating adults with advanced or metastatic esophageal squamous cell carcinoma (ESCC) following prior systemic chemotherapy. The nod marks the first U.S. indication for Tevimbra, expected to be available in the latter half of 2024. Tevimbra’s approval was supported by the results of the global phase 3 RATIONALE 302 trial, which demonstrated a significant survival advantage over traditional chemotherapy. Patients treated with Tevimbra experienced a median overall survival of 8.6 months, compared to 6.3 months for those on chemotherapy. The drug has already received approval in Europe for the same condition and is under review for additional indications, including first-line ESCC treatment and as a therapy for non-small cell lung cancer. BeiGene is also conducting numerous trials to explore Tevimbra broader potential across various cancer types, with over 900,000 patients worldwide already treated. Initially, BeiGene and Novartis collaborated on developing Tevimbra under a 2021 agreement that allowed Novartis to lead regulatory efforts and commercialize the drug worldwide post-approval. They've now amended this arrangement, granting BeiGene exclusive global rights to develop, manufacture and sell Tevimbra.