On November 27, 2023 Medivir AB (Nasdaq Stockholm: MVIR), a pharmaceutical company focused on developing innovative treatments for cancer in areas of high unmet medical need, reported that it has finalized the development of an updated formulation of fostrox, suitable for commercial manufacture (Press release, Medivir, NOV 27, 2023, View Source [SID1234637985]). HCC is a potentially life-threatening form of liver cancer and the third leading cause of cancer-related death worldwide. The need for new treatments is high and the development of an updated commercial formulation is an additional step towards fostrox becoming a treatment option for HCC patients.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The development efforts have been carried out by Quotient Sciences, Medivir’s partner for formulation development and manufacture of drug product.

Fostrox is currently being evaluated in an ongoing phase 1b/2a study in combination with Lenvima, a tyrosine kinase inhibitor. It is an open-label, multicenter study and includes patients with HCC for whom current first- or second-line treatment has proven ineffective or is not tolerable. It has the potential to provide HCC patients, who have progressed on current first line standard of care, with an alternative option where no other treatments are approved.

With the study fully recruited and ~50% of patients still on treatment, interim data indicates clinical benefit without compromising safety, when fostrox is added to Lenvima in second-line HCC. Based on these promising data, together with the lack of approved medical treatments after tumor progression on first line standard of care, the company has communicated the plan to initiate phase 2b study with accelerated approval intent.

A formulation suitable for commercial manufacture is a critical component in clinical studies with regulatory intent. With the formulation development program successfully finalized, the next step is to manufacture three different strengths of fostrox together with placebo to ensure momentum in the fostrox development program and enable a timely start of the planned phase 2b study.

– "With the plans to initiate a phase 2b study with registrational intent, it is imperative that we use the formulation intended for commercial launch in the study. We are very pleased with our collaboration with Quotient Sciences on this updated, commercial formulation and having the formulation at this stage enables us to keep maximum momentum in the fostrox development program," says Jens Lindberg, CEO at Medivir.

On November 27, 2023 AbbVie (NYSE: ABBV) reported updates from the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) for epcoritamab, an investigational T-cell engaging bispecific antibody administered subcutaneously, for relapsed or refractory (R/R) follicular lymphoma (FL) (Press release, AbbVie, NOV 27, 2023, View Source [SID1234637984]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The FDA has granted Breakthrough Therapy Designation (BTD) to epcoritamab-bysp (EPKINLY) for the treatment of adult patients with R/R FL after two or more therapies. Additionally, the EMA has validated a Type II application for epcoritamab (TEPKINLY) for the same indication. If approved, R/R FL would become the second conditionally approved indication for epcoritamab in the European Union.

"The FDA granted BTD and validated European application are an important step in our commitment to improving the lives of patients with relapsed/refractory follicular lymphoma, a complex blood cancer with limited treatment options," said Mariana Cota Stirner, M.D., Ph.D., vice president, therapeutic area head for hematology, AbbVie. "Together with Genmab, we are continuing to investigate epcoritamab as a potential core therapy for multiple B-cell malignancies, including diffuse large B-cell lymphoma and now follicular lymphoma."

These updates were supported by previously announced results from the Phase 1/2 EPCORE NHL-1 clinical trial evaluating the safety and preliminary efficacy of subcutaneous epcoritamab in 128 adult patients with relapsed, progressive or refractory CD20+ mature B-cell non-Hodgkin’s lymphoma (NHL), including FL. Data from the FL cohort of the trial, including an optimized dosing schedule allowing for outpatient administration, will be presented at the upcoming Annual Meeting and Exposition of the American Society of Hematology (ASH) (Free ASH Whitepaper) in December 2023.

BTD may expedite the development and review of investigational medicines by the FDA for serious or life-threatening diseases in cases where preliminary clinical evidence shows that a therapy may provide substantial improvements over available therapies.1 EMA validation confirms that the submitted regulatory application is complete and initiates the scientific review process by the EMA’s Committee for Medicinal Products for Human Use (CHMP).

FL is typically an indolent, or slow-growing, form of NHL that arises from B-cell lymphocytes.2 It is the second most common form of NHL overall, accounting for 20 percent to 30 percent of all NHL cases globally.3 Although FL is an indolent lymphoma, it is considered incurable with current standard of care therapies.4,5

Epcoritamab is being co-developed by AbbVie and Genmab as part of the companies’ oncology collaboration. The companies will share commercial responsibilities in the U.S. and Japan, with AbbVie responsible for further global commercialization.

About the Phase 1/2 EPCORE NHL-1 Trial
EPCORE NHL-1 is an open-label, multi-center safety and preliminary efficacy trial of epcoritamab that consists of three parts: a Phase 1 first-in-human, dose escalation part; a Phase 2a expansion part; and a Phase 2a dose optimization part. The trial was designed to evaluate subcutaneous epcoritamab in adult patients with relapsed, progressive or refractory CD20+ mature B-cell non-Hodgkin’s lymphoma (NHL), including follicular lymphoma (FL). In the Phase 2a expansion part, additional patients are being enrolled to further explore the safety and efficacy of epcoritamab in three cohorts of patients with different types of relapsed or refractory (R/R) B-cell NHLs who have limited therapeutic options. The dose optimization part evaluates the potential for alternative step-up dosing regimens to help further minimize Grade 2 cytokine release syndrome (CRS) and mitigate Grade ≥3 CRS. The application for BTD included additional data from this cohort of patients. The primary endpoint of the expansion part was overall response rate as assessed by an independent review committee. Secondary efficacy endpoints included duration of response, complete response rate, duration of complete response, progression-free survival, and time to response as determined by the Lugano criteria. Overall survival, time to next therapy, and rate of minimal residual disease negativity were also evaluated as secondary efficacy endpoints.

About Epcoritamab

Epcoritamab is an investigational IgG1-bispecific antibody created using Genmab’s proprietary DuoBody technology and administered subcutaneously. Genmab’s DuoBody-CD3 technology is designed to direct cytotoxic T cells selectively to elicit an immune response toward target cell types. Epcoritamab is designed to simultaneously bind to CD3 on T cells and CD20 on B cells and induces T-cell-mediated killing of CD20+ cells.6

Epcoritamab (approved under the brand name EPKINLY in the United States and TEPKINLY in the European Union) has received regulatory approval in adults with certain types of large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL), globally. EPKINLY is approved under the FDA’s Accelerated Approval program based on response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Use of epcoritamab in FL is not approved in the U.S. or in the EU. AbbVie will continue to pursue regulatory submissions for epcoritamab across international markets.

Genmab and AbbVie continue to evaluate the use of epcoritamab as a monotherapy, and in combination, across lines of therapy in a range of hematologic malignancies. This includes three ongoing Phase 3, open-label, randomized trials including a trial evaluating epcoritamab as a monotherapy in patients with R/R DLBCL (NCT: 04628494) compared to investigator’s choice chemotherapy, a Phase 3 trial evaluating epcoritamab in combination with R-CHOP in adult patients with newly diagnosed DLBCL (NCT: 05578976), and a Phase 3 clinical trial evaluating epcoritamab in combination with rituximab and lenalidomide (R2) in patients with R/R FL (NCT: 05409066). Epcoritamab is not approved to treat patients with newly diagnosed DLBCL or with FL. The safety and efficacy of epcoritamab has not been established for these investigational uses. Please visit clinicaltrials.gov for more information.

EPKINLY (epcoritamab-bysp) U.S. USES AND IMPORTANT SAFETY INFORMATION

USE

EPKINLY is a prescription medicine used to treat adults with certain types of diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma that has come back (relapsed) or that did not respond to previous treatment (refractory), and who have received 2 or more treatments for their cancer.

EPKINLY is approved based on patient response data. A study is ongoing to confirm the clinical benefit of EPKINLY. It is not known if EPKINLY is safe and effective in children.

IMPORTANT SAFETY INFORMATION

Important Warnings—EPKINLY can cause serious side effects, including:

Cytokine Release Syndrome (CRS). CRS is common during treatment with EPKINLY and can be serious or life-threatening. Tell your healthcare provider or get medical help right away if you develop symptoms of CRS, including fever of 100.4°F (38°C) or higher, dizziness or lightheadedness, trouble breathing, chills, fast heartbeat, feeling anxious, headache, confusion, shaking (tremors), or problems with balance and movement, such as trouble walking.

Due to the risk of CRS, you will receive EPKINLY on a "step-up" dosing schedule. The step-up dosing schedule is when you receive smaller "step-up" doses of EPKINLY on day 1 and day 8 of your first cycle of treatment (cycle 1). You will receive your first full dose of EPKINLY on day 15 of cycle 1. If your dose of EPKINLY is delayed for any reason, you may need to repeat the step-up dosing schedule. Before each dose in cycle 1, you will receive medicines to help reduce your risk of CRS. Your healthcare provider will decide if you need to receive medicine to help reduce your risk of CRS with future cycles.

Neurologic problems. EPKINLY can cause serious neurologic problems that can be life-threatening and lead to death. Neurologic problems may happen days or weeks after you receive EPKINLY. Your healthcare provider may refer you to a healthcare provider who specializes in neurologic problems. Tell your healthcare provider right away if you develop any symptoms of neurologic problems, including trouble speaking or writing, confusion and disorientation, drowsiness, tiredness or lack of energy, muscle weakness, shaking (tremors), seizures, or memory loss.
Due to the risk of CRS and neurologic problems, you should be hospitalized for 24 hours after receiving your first full dose of EPKINLY on day 15 of cycle 1. Your healthcare provider will monitor you for symptoms of CRS and neurologic problems during treatment with EPKINLY, as well as other side effects, and treat you if needed. Your healthcare provider may temporarily stop or completely stop your treatment with EPKINLY if you develop CRS, neurologic problems, or any other side effects that are severe.

Do not drive or use heavy or potentially dangerous machinery if you develop dizziness, confusion, tremors, drowsiness, or any other symptoms that impair consciousness until your symptoms go away. These may be symptoms of CRS or neurologic problems.

EPKINLY can also cause other serious side effects, including:

Infections. EPKINLY can cause serious infections that may lead to death. Your healthcare provider will check you for symptoms of infection before and during treatment. Tell your healthcare provider right away if you develop any symptoms of infection during treatment, including fever of 100.4°F (38°C) or higher, cough, chest pain, tiredness, shortness of breath, painful rash, sore throat, pain during urination, or feeling weak or generally unwell.
Low blood cell counts. Low blood cell counts are common during treatment with EPKINLY and can be serious or severe. Your healthcare provider will check your blood cell counts during treatment. EPKINLY may cause low blood cell counts, including low white blood cell counts (neutropenia), which can increase your risk for infection; low red blood cell counts (anemia), which can cause tiredness and shortness of breath; and low platelet counts (thrombocytopenia), which can cause bruising or bleeding problems.
Your healthcare provider may temporarily stop or completely stop treatment with EPKINLY if you develop certain side effects.

Before you receive EPKINLY, tell your healthcare provider about all of your medical conditions, including if you:

have an infection.
are pregnant or plan to become pregnant. EPKINLY may harm your unborn baby. Females who are able to become pregnant: Your healthcare provider should do a pregnancy test before you start treatment with EPKINLY. You should use effective birth control (contraception) during treatment and for 4 months after your last dose of EPKINLY. Tell your healthcare provider if you become pregnant or think that you may be pregnant during treatment with EPKINLY.
are breastfeeding or plan to breastfeed. It is not known if EPKINLY passes into your breast milk. Do not breastfeed during treatment with EPKINLY and for 4 months after your last dose of EPKINLY.
Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

The most common side effects of EPKINLY include CRS, tiredness, muscle and bone pain, injection site reactions, fever, stomach-area (abdominal) pain, nausea, and diarrhea.

These are not all the possible side effects of EPKINLY. Call your doctor for medical advice about side effects.

You are encouraged to report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch or to Genmab US, Inc. at 1-855-4GENMAB (1-855-443-6622).

Please see the Full Prescribing Information and Medication Guide, including Important Warnings.

Globally, prescribing information varies; refer to the individual country product label for complete information.

On November 27, 2023 Akeso (9926. HK) reported that the AK104-303 Phase III trial, which investigated cadonilimab (Akeso’s PD-1/CTLA-4 bispecific antibody) combined with platinum-based chemotherapy +/- bevacizumab, has met one of its primary endpoints of progression-free survival (PFS) for first-line treatment of recurrent/metastatic cervical cancer (R/M CC), with p-value of less than 0.0001 (Press release, Akeso Biopharma, NOV 27, 2023, View Source [SID1234637982]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The AK104-303 trial represents a significant milestone as the first Phase III clinical trial investigating the combination of a PD-1/CTLA-4 bispecific antibody with platinum-based chemotherapy +/- bevacizumab for first-line treatment of recurrent/metastatic R/M CC. The primary endpoints of the study were progression-free survival (PFS) and overall survival (OS) assessed by blinded independent central review (BICR) based on RECIST v1.1 criteria. In the study, approximately 26% of patients had tumors with PD-L1 CPS < 1. Public data indicates that approximately 11% of patients in the KEYNOTE-826 study had PD-L1 CPS < 1.

During a pre-specified interim analysis conducted by an independent data monitoring committee (IDMC) in the intent-to-treat (ITT) population, cadonilimab combined with platinum-based chemotherapy +/- bevacizumab demonstrated a statistically significant and clinically meaningful PFS benefit compared to placebo combined with platinum-based chemotherapy +/- bevacizumab in all-comer patients, irrespective of their PD-L1 status, including both the PD-L1 CPS ≥ 1 and PD-L1 CPS < 1 populations.

A trend in improvement in overall survival (OS), which is the other primary endpoint, was observed for cadonilimab combination versus placebo in combination with platinum-based chemotherapy +/- bevacizumab. Data for OS were not mature at this interim analysis and the trial will continue as planned to assess OS.

The safety profile of cadonilimab remains consistent with previous clinical results with no new safety signals identified.

The successful achievement of the primary endpoint of PFS in the Phase III trial of cadonilimab for first-line cervical cancer is yet another milestone for the drug in first-line therapy, following the earlier achievement of the primary endpoint in first-line gastric cancer and the planned sNDA by Akeso.

In Jun 2022, cadonilimab was approved for second/third line treatment of advanced cervical cancer. With the encouraging outcomes observed in cadonilimab’s registration trials across diverse indications, especially in first-line therapies, the potential patient population eligible for cadonilimab is anticipated to expand rapidly. This expansion will effectively harness the clinical value of this novel bispecific immuno-oncology therapy, bringing benefits to a larger number of patients.

"We are delighted to once again witness the remarkable improvement in progression-free survival achieved with cadonilimab in first-line treatment of all-comer patients with advanced cervical cancer," said Dr. Yu Xia, Founder, Chairman, President, and CEO of Akeso. "This outcome not only reaffirms the advantages of cadonilimab observed in the Phase II trials of cervical cancer and other trials, particularly in gastric cancer, but also further validates its exceptional clinical value in cancer treatment. We extend our heartfelt appreciation to all the researchers, participants, and patients who contributed to this trial. It is thanks to your efforts and dedication that a broader population of cervical cancer patients in China will have the opportunity to undergo a novel bispecific IO therapy, thereby enhancing treatment effectiveness and improving survival rates."

About Cadonilimab

Cadonilimab is a first-in-class bispecific antibody that targets both PD-1 and CTLA-4 developed by Akeso. It is a symmetric tetravalent bispecific antibody with a crystallizable fragment (Fc)-null design. In addition to demonstrating biological activity similar to that of the combination of CTLA-4 and PD-1 antibodies, cadonilimab possesses higher binding avidity in a high-density PD-1 and CTLA-4 setting than in a low-density PD-1 setting, while a mono-specific anti-PD-1 antibody does not demonstrate this differential activity. With no binding to Fc receptors, cadonilimab shows minimal antibody-dependent cellular cytotoxicity, antibody-dependent cellular phagocytosis, and interleukin-6 (IL-6)/IL-8 release. These features all likely contribute to significantly lower toxicities of cadonilimab observed in the clinic. Higher binding avidity of cadonilimab in a tumor-like setting and Fc-null design may lead to better drug retention in tumors and improve safety while achieving anti-tumor efficacy.

The China National Medical Products Administration has approved cadonilimab for recurrent or metastatic cervical cancer. Cadonilimab has been included and recommended in multiple clinical guidelines such as CSCO. Cadonilimab has been engaged in more than 60 ongoing clinical trials including investigator-initiated studies. Phase 3 study of cadonilimab for first-line treatment of gastric cancer has met its endpoint of PFS. A phase 3 study of cadonilimab as an adjuvant treatment for hepatocellular carcinoma is ongoing. Furthermore, a Phase 3 study comparing cadonilimab with chemotherapy to tislelizumab Injection with chemotherapy is underway for the first-line treatment of PD-L1 expression-negative non-small cell lung cancer.

On November 27, 2023 TC BioPharm (Holdings) PLC ("TC BioPharm" or the "Company") (NASDAQ: TCBP) a clinical stage biotechnology company developing platform allogeneic gamma-delta T cell therapies for cancer, reported that the FDA provides clearance on the Company’s investigational new drug (IND) application for a Phase 1B study in relapse/refractory Acute Myeloid Leukemia (AML) (Press release, TC Biopharm, NOV 27, 2023, View Source [SID1234637981]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The Phase 1B study, dubbed ACHIEVE2, will be a 9 patient, dose escalating study measuring for safety and dose optimization. The Open-label, multi-center study conducted in 2 parts (dose escalation followed by dose expansion) will evaluate safety, persistence/expansion, and preliminary efficacy of single and multiple IV doses of TCB008 in patients with AML or MDS/AML. Patients may be reinfused with TCB008 up to 3 times following initial infusion as deemed appropriate by the investigator or designee should protocol specified criteria be met.

"The acceptance of the TCB-008 IND is a significant milestone for TC BioPharm and reflects execution of our strategic plan which we announced to shareholders in April. TC BioPharm will continue to work towards its primary goal of establishing a better method of treatment for the millions of people around the world suffering blood and bone marrow cancer as we establish TCB008 the standard of care for these patients, with higher quality of life and extended remission of these devastating diseases," said Bryan Kobel, Chief Executive Officer of TC BioPharm.

Additionally, the Company will be continuing the UK ACHIEVE trial in AML, expecting to submit amendments to the protocol before year-end to align the dosing and other criteria with the ACHIEVE2 trial of TCBP’s lead product.

Mr. Kobel continued, "TCB-008 has shown promising results previously as a therapeutic in late stage AML patients and we believe the safety profile and mechanism of action combine to make the asset a therapeutic for a number of blood related cancers, as well as an ideal combination treatment in oncology indications. As we look to 2024, we see copious milestones and inflection points, both in our US trial as well as our ongoing ACHIEVE trial and our platform expansion. Since announcing our refocused strategy this year, TC BioPharm has continued to execute and deliver key milestones. We expect to continue to execute in 2024 and appreciate shareholders believing in our vision. Our team will maintain its focus on expanding our platform and generating strong clinical data as the leader in the gamma delta space, and we expect shareholder value will improve accordingly."

About TCB008 (OmnImmune)
OmnImmune an allogeneic unmodified cell therapy consisting of activated and expanded gamma delta T cells. The trial, for treatment of patients suffering from relapse/refractory Acute Myeloid Leukemia (AML). The therapeutic comprises GDT cells sourced from healthy donors, expanded and activated in large numbers before being purified and formulated for infusion into patients. OmnImmune is a frozen and thawed product, now "banked" from donor derived cells.

On November 27, 2023 RemeGen Co. Ltd. ("RemeGen" or "the Company") (9995.HK, SHA: 688331), a commercial-stage biotechnology company, reported its two Phase II, open-label, multicenter, single-arm studies for Disitamab Vedotin (RC48-C005 and RC48-C009) have demonstrated consistent efficacy in patients with HER2-positive (immunohistochemistry 3+ or 2+) locally advanced or metastatic urothelial carcinoma (mUC) who have progressed through at least one previous line of systemic chemotherapy (Press release, RemeGen, NOV 27, 2023, View Source [SID1234637980]). The pooled analysis of these two studies have been published in the latest issue of the world-renowned Journal of Clinical Oncology (JCO).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The pivotal Phase II trial (RC48-C005, NCT03507166) was to evaluate the efficacy and safety of disitamab vedotin in HER2-positive previously treated advanced urothelial carcinoma (UC) patients. Based on the early positive results and the guidance of the National Medical Products Administration (NMPA) in China, the RC48-C005 trial enrollment was prematurely halted, and a subsequent study (RC48-C009, NCT03809013) was conducted to validate the initial findings. A combined analysis of the two studies with adaptive trial design endorsed by the NMPA was required to improve the estimation precision of both efficacy and safety. Both trials demonstrated promising efficacy and manageable safety profiles for patients with metastatic urothelial carcinoma (mUC) who had previously experienced progression on systematic chemotherapy. Based on the robust results from both studies, in January 2022, disitamab vedotin gained conditional approval in China for patients with mUC resistant to platinum-based therapies.

The Company’s CEO, Dr. Jianmin Fang commented, "The reported results demonstrate that disitamab vedotin is among the first HER2-targeted therapies to have meaningful clinical value against metastatic or locally advanced urothelial cancer. These two China-based studies have led to the drug’s accelerated approval in China and large international studies (NCT04879329, NCT05911295) initiated by our partner, Seagen Inc., are underway."

Key Results

One hundred and seven patients were enrolled in total and received a 2 mg/kg IV infusion of disitamab vedotin treatment once every two weeks. The primary end point was objective response rate (ORR) assessed by a blinded independent review committee (BIRC). Progression-free survival (PFS), overall survival (OS), and safety were also assessed. The overall confirmed ORR by BIRC was 50.5% (95% CI, 40.6 to 60.3). Consistent results were observed in prespecified subgroups including patients with liver metastasis and patients previously treated with anti–PD-1/L1 therapies. By the cutoff date of May 10, 2022, the median duration of response was 7.3 months (95% CI, 5.7 to 10.8). The median PFS and OS were 5.9 months (95% CI, 4.3 to 7.2) and 14.2 months (95% CI, 9.7 to 18.8), respectively. The most common treatment-related adverse events (TRAEs) were peripheral sensory neuropathy (68.2%), leukopenia (50.5%), AST elevation (42.1%), and neutropenia (42.1%). Fifty-eight (54.2%) patients experienced grade ≥3 TRAEs, including peripheral sensory neuropathy (18.7%) and neutropenia (12.1%).

Locally advanced or metastatic urothelial carcinoma (UC) has a poor prognosis, with only about 5% of patients at stage IV (metastatic) surviving longer than five years. Platinum-based chemotherapy remains the first-line standard of care for advanced UC with the objective response rates (ORRs) of 44.6%-72% historically and the median overall survival (mOS) of 14.0-15.2 months.

"We are firmly committed to providing effective and safe treatment options to prolong and improve the quality of lives of patients with HER2-positive locally advanced or metastatic urothelial cancer. In these studies, we were pleased to find that disitamab vedotin has consistent efficacy and manageable safety in patients with chemotherapy-refractory mUC," said the principal investigator of the studies, Dr. Guo Jun.