Kitrudda's SC Formulation Expands Bladder Cancer Treatment in Europe
Altheogen's (196170) subcutaneous (SC) formulation technology, applied to Keytruda, has expanded its bladder cancer treatment territory in Europe. The approval scope has been widened to include patients who can receive the treatment, following those who were previously unable to undergo cisplatin-based chemotherapy. With an estimated 50,000 new cases of muscle-invasive bladder cancer diagnosed annually in Europe, the commercialization potential for Kitrudda SC is also expanding.
This approval encompasses both the intravenous (IV) formulation of Keytruda and the SC formulation utilizing Altheogen's ALT-B4 technology. As Keytruda secures a new indication, the SC formulation's treatment scope broadens, further strengthening Altheogen's long-term royalty growth foundation.
#### Expanding Bladder Cancer Treatment in Europe: Cisplatin-Suitable Patients Included
The European approval now includes patients suitable for cisplatin treatment, broadening the scope of bladder cancer therapy.
MSD's Keytruda and Padcev Combination Therapy Gains European Approval
MSD announced on November 21st that the European Commission has approved its combination therapy of Keytruda and Pfizer/Astellas' antibody-drug conjugate (ADC) treatment, Padcev, as a pre- and post-surgical treatment for muscle-invasive bladder cancer (MIBC) patients.
The approval also includes the SC formulation of Keytruda, which utilizes Altheogen's ALT-B4 technology. In the U.S., this formulation is marketed under the name Keytruda Qlex. The approval is valid across the 27 European Union member states, as well as Iceland, Liechtenstein, and Norway, totaling 30 countries.
[Source: MSD, Official Announcement of European Approval for Keytruda and Padcev Combination Therapy]
In Europe, the combination therapy of Keytruda and Padcev was previously approved in June for patients unsuitable for cisplatin-based chemotherapy. With this latest approval, the therapy can now be used for patients regardless of their suitability for cisplatin treatment, making it the first PD-1 inhibitor and ADC combination therapy in Europe with such flexibility.
A New Treatment Option for Bladder Cancer: Combining Immunotherapy and ADC
The treatment approach encompasses both neoadjuvant therapy prior to surgery and adjuvant therapy following bladder removal. This introduces a novel therapeutic choice by combining immunotherapy and ADC with traditional chemotherapy.
The pivotal phase 3 clinical trial, KEYNOTE-B15, served as the basis for approval. In this trial, the combination of Keytruda and Padcev demonstrated a significant reduction in the risk of disease progression, recurrence, or death by 47%, compared to standard chemotherapy. Additionally, the pathological complete response rate was notably higher at 55.8%, surpassing the control group's rate of 32.5%.
The size of the European bladder cancer market is also noteworthy. According to MSD, approximately 208,291 new cases of bladder cancer are expected to be diagnosed in Europe in 2024. Some clinical guidelines classify around 25% of new patients as having muscle-invasive bladder cancer. This translates to an annual estimate of approximately 52,000 cases.
This figure represents the estimated number of new muscle-invasive bladder cancer patients across Europe, and it differs from the actual number of patients who may be prescribed the Keytruda and Padcev combination therapy. The approved indication is limited to adult patients with resectable disease.
ALT-B4 Commercialization: European Approval Expands Treatment Scope
The European approval, granted 34 days after the positive opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP), marks a significant milestone for the commercialization of ALT-B4.
Keytruda SC's initial adult indication, approved after a 61-day process following the CHMP's positive opinion on September 19, 2025, set a precedent. Subsequently, the KEYNOTE-B96 ovarian cancer indication and the cisplatin-ineligible bladder cancer indication were approved in 35 and 34 days, respectively. This latest approval for cisplatin-eligible bladder cancer follows a similar rapid timeline.
As additional indications receive final approval within a month of CHMP's positive opinions, Keytruda SC's treatment scope in Europe continues to expand rapidly.
A key advantage for Altheogen is the inclusion of the SC formulation in the expanding indications for Keytruda. With each new indication, they can broaden the commercialization potential of their existing ALT-B4 products without the need for separate novel drug development.
Altheogen's ALT-B4 Technology: Expanding Commercial Opportunities
Altheogen's ALT-B4 technology, which converts intravenous medications into subcutaneous formulations, has proven to be a game-changer. Through their licensing agreement with MSD, Altheogen has established a lucrative business model, securing revenue from the commercialization of Keytruda SC.
Keytruda SC has already entered the commercialization phase in the United States and Europe, and with the expansion of its approved indications, the patient population eligible for prescription is growing. This recent approval for bladder cancer not only signifies the successful transition to SC formulation in existing treatment areas but also opens doors for increased sales in new therapeutic domains.
As Keytruda SC's actual prescriptions and sales increase, it is expected to have a positive impact on Altheogen's royalty revenue. The global expansion of blockbuster medications and their approved indications showcases the growing commercial utilization of domestic bio-platform technologies.
This development highlights the potential for significant returns and further underscores the importance of innovative technologies in the pharmaceutical industry.
