Merck Secures European Approval for Kitruda SC with Promising CHMP Opinion

Keytruda Subcutaneous Formulation Poised for European Approval, Alteogen’s Tech at Core

Brussels, Belgium – A Breakthrough in Cancer Treatment is on the Horizon as Merck & Co. (MSD outside of the US and Canada) has received a favorable opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human use (CHMP) regarding its Keytruda subcutaneous (SC) formulation. The decision, impacting all current European indications for the blockbuster immunotherapy, signals a potential shift towards more accessible and efficient cancer care.

What the CHMP Recommendation Means

The CHMP’s positive opinion applies to all approved indications of Keytruda for adult patients across Europe. Importantly, a positive opinion was also issued for new indications in head and neck squamous cell carcinoma (HNSCC). This complete endorsement significantly broadens the scope of the anticipated approval. the U.S. food and drug Administration (FDA) is expected to deliver its decision on the Keytruda SC formulation by October 23rd.

The Role of alteogen’s Technology

The Keytruda SC formulation leverages merck’s pembrolizumab combined with Berahyaluronidase Alfa (ALT-B4), a proprietary technology developed by Alteogen. This innovative combination allows for subcutaneous administration – a faster and more convenient method compared to conventional intravenous (IV) infusions.

According to Alteogen CEO Park Soon-jae,this approval brings the company closer to realizing the potential of its ALT-B4 platform.”We are dedicated to providing cancer patients and healthcare professionals with a swift and straightforward subcutaneous injection option globally,” stated Park.

Clinical Trial Results Support the New Formulation

the CHMP’s recommendation is grounded in the results of the PIVOTAL 3475A-D77 clinical trial. Data from the trial demonstrated comparable pharmacokinetic (PK) profiles between Keytruda SC and the existing IV formulation. Crucially,the overall response rate (ORR) and progression-free survival (PFS) remained consistent with those observed in patients receiving IV Keytruda.

The subcutaneous injection offers a substantial time savings, taking approximately one minute for a 395 mg dose administered every three weeks, or two minutes for a 790 mg dose every six weeks.

A Strengthened Partnership

Alteogen initially entered into a licensing agreement with Merck in June 2020, granting rights to utilize ALT-B4. A subsequent agreement in February 2024 refined the original terms, providing Alteogen with potential for additional milestones and royalties linked to the success of Keytruda SC. This demonstrates a deepening collaboration between the two companies.

Feature	Keytruda IV	Keytruda SC
Administration Route	Intravenous (IV) Infusion	Subcutaneous (SC) Injection
Typical Duration	30-60 Minutes	1-2 Minutes
Pharmacokinetics	Standard	Comparable to IV
Overall Response Rate	Consistent with IV	Consistent with IV

Did You Know? Hyaluronidase enzymes, like ALT-B4, help to break down hyaluronic acid in the tissue, allowing for faster absorption of larger molecule drugs when injected subcutaneously.

Pro Tip: Subcutaneous injections are generally less stressful for patients than IV infusions and can be administered in a wider range of clinical settings.

The growing Importance of Subcutaneous Drug Delivery

Subcutaneous drug delivery is rapidly gaining traction in the pharmaceutical industry thanks to its benefits for both patients and healthcare providers. The global subcutaneous drug delivery market is projected to reach USD 7.67 billion by 2030, expanding at a CAGR of 6.5% according to Grand View Research. This growth is fueled by the demand for convenient, patient-centric treatment options and the increasing advancement of large-molecule drugs.

The development of technologies enabling subcutaneous administration of biologics, like Alteogen’s ALT-B4, are crucial to fully capitalize on this trend. Challenges remain in ensuring consistent drug delivery and patient comfort, but ongoing research and innovation are steadily overcoming thes hurdles.

Frequently Asked Questions about Keytruda SC

1. what is Keytruda SC? Keytruda SC is a subcutaneous formulation of pembrolizumab, the active ingredient in Keytruda, designed for faster and easier administration.
2. What is ALT-B4 and how does it work? ALT-B4 is a proprietary technology developed by Alteogen that enables subcutaneous delivery of large molecule drugs by breaking down hyaluronic acid in the tissue.
3. how long does Keytruda SC take to administer? Keytruda SC takes approximately 1-2 minutes to administer, compared to 30-60 minutes for traditional IV infusions.
4. Is Keytruda SC as effective as IV Keytruda? Clinical trials have shown that Keytruda SC has comparable pharmacokinetic profiles, overall response rates, and progression-free survival to IV Keytruda.
5. When is the expected final approval for Keytruda SC in Europe? Final approval from the European Commission is anticipated in the fourth quarter of this year.
6. what are the potential benefits of subcutaneous administration for cancer patients? Subcutaneous administration offers convenience, reduced treatment time, and potentially lower healthcare costs.
7. What does this mean for Alteogen as a company? The potential approval of Keytruda SC validates Alteogen’s ALT-B4 technology and positions the company for further growth and collaboration.

What impact do you think this faster administration method will have on patient compliance with Keytruda therapy? Will this open doors for wider use of this critical immunotherapy?

Share your thoughts in the comments below and help us continue the conversation!

What training will healthcare professionals require to confidently and competently administer Kitruda SC?

What is Kitruda SC and Why Does Approval Matter?

Merck’s Keytruda (pembrolizumab) has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for a new subcutaneous (SC) formulation, Kitruda SC. This approval expands treatment options for patients battling various cancers, offering a perhaps more convenient administration method compared to the existing intravenous (IV) infusion. The CHMP opinion paves the way for a European Commission decision, expected in the coming months, which would grant full marketing authorization. This is important news for oncology, immunotherapy, and patient care across Europe.

Understanding the Subcutaneous Formulation

Kitruda SC delivers the same pembrolizumab antibody as the IV formulation,but through a subcutaneous injection – similar to how many diabetes medications are administered. This offers several potential advantages:

* Reduced chair Time: SC administration typically takes significantly less time than IV infusions, potentially freeing up valuable time for both patients and healthcare staff.

* Increased Convenience: Patients may be able to receive treatment in a more convenient setting, potentially even at home under appropriate medical supervision, improving quality of life.

* Potential for Reduced Costs: While not immediately guaranteed, streamlined administration could lead to lower healthcare costs associated with infusion centers and staffing.

The development of Kitruda SC involved rigorous clinical trials to demonstrate comparable efficacy and safety to the IV formulation.Data presented at major oncology conferences, like the ASCO Annual Meeting, highlighted the non-inferiority of the SC route.

Approved Cancer Types for Kitruda (IV and SC) in Europe

The CHMP opinion for Kitruda SC covers the same indications currently approved for the IV formulation of Keytruda in Europe. These include:

* Melanoma: Advanced melanoma, both unresectable or metastatic.

* non-Small Cell Lung Cancer (NSCLC): First-line treatment in combination with chemotherapy for certain types of NSCLC, and as monotherapy for patients with high PD-L1 expression.

* Classical hodgkin Lymphoma (cHL): Relapsed or refractory cHL.

* Certain Types of Head and neck squamous Cell Carcinoma (HNSCC): Recurrent or metastatic HNSCC.

* Microsatellite Instability-High (MSI-H) Cancers: Treatment of unresectable or metastatic MSI-H tumors.

* Esophageal Cancer: Locally advanced or metastatic esophageal cancer.

This broad range of applications underscores Keytruda’s importance as a cornerstone of modern cancer treatment. The SC formulation simply offers a new way to deliver this vital therapy.

Clinical Trial Data Supporting Kitruda SC

The approval is based on data from several Phase 1 and Phase 3 clinical trials. Key findings include:

1. Pharmacokinetic Similarity: Studies demonstrated that the SC formulation delivers similar drug concentrations in the body compared to the IV formulation, ensuring comparable efficacy.
2. Non-Inferiority in Efficacy: Trials showed that Kitruda SC was not inferior to IV Keytruda in terms of objective response rate (ORR),progression-free survival (PFS),and overall survival (OS) across various cancer types.
3. Comparable Safety Profile: The safety profile of Kitruda SC was consistent with that of the IV formulation, with no new or unexpected adverse events identified. Common side effects associated with Keytruda, such as fatigue, rash, and immune-related adverse events, were observed at similar rates.

these results were published in peer-reviewed journals like The Lancet Oncology and presented at prominent medical meetings, solidifying the scientific basis for the approval.

impact on Immunotherapy Landscape

The introduction of Kitruda SC represents a significant advancement in immunotherapy. Immunotherapy, including checkpoint inhibitors like Keytruda, has revolutionized cancer treatment by harnessing the power of the patient’s own immune system to fight cancer.

* Increased Patient Access: The convenience of SC administration could improve access to immunotherapy for patients in remote areas or with limited mobility.

* Enhanced treatment Adherence: Reduced treatment time and increased convenience may lead to better patient adherence to therapy.

* Potential for Personalized Medicine: Future research may explore the possibility of tailoring the administration route (IV vs. SC) based on individual patient characteristics and preferences.

Practical Considerations for Healthcare Professionals

With the anticipated approval, healthcare professionals should prepare for the implementation of Kitruda SC:

* Training: Proper training on SC injection technique is crucial to ensure safe and effective administration. Merck will likely provide thorough training resources.

* Patient Education: Patients need to be educated about the SC formulation, including injection site rotation, potential side effects, and self-administration (if applicable).

* Injection Site Management: monitoring for local injection site reactions is vital.

* Reimbursement and Access: Ensuring appropriate reimbursement and access to Kitruda SC will be essential to maximize its benefit to patients.

Future Directions and Ongoing research

Merck continues to invest in research and development to further improve Keytruda and expand