Tremelimumab-actl - Biologic Drug Details

Summary for tremelimumab-actl

Tradenames:	1
High Confidence Patents:	0
Applicants:	1
BLAs:	1
Suppliers: see list	1
Recent Clinical Trials:	See clinical trials for tremelimumab-actl

Recent Clinical Trials for tremelimumab-actl

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Georgetown University	Phase 2
AbbVie	Phase 2/Phase 3
Peking Union Medical College	Phase 1/Phase 2

See all tremelimumab-actl clinical trials

Pharmacology for tremelimumab-actl

Mechanism of Action	CTLA-4-directed Antibody Interactions
Physiological Effect	Increased T Lymphocyte Activation
Established Pharmacologic Class	CTLA-4-directed Blocking Antibody

Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

1. Brand-side disclosures in response to biosimilar applications

These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

2. General brand-side disclosures

These patents were identified from searching drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

3. Patents from broad patent text search

For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for tremelimumab-actl Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for tremelimumab-actl Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for tremelimumab-actl Derived from Patent Text Search

No patents found based on company disclosures

Market Dynamics and Financial Trajectory for Tremelimumab-actl (Imjudo)

Introduction to Tremelimumab-actl (Imjudo)

Tremelimumab-actl, marketed as Imjudo, is a CTLA-4–blocking antibody developed by AstraZeneca. It has been approved by the US FDA for the treatment of adult patients with unresectable hepatocellular carcinoma (HCC) and metastatic non-small cell lung cancer (NSCLC) in combination with other therapies[4][5].

FDA Approval and Indications

The FDA approved Imjudo in combination with durvalumab (Imfinzi), a PD-L1–blocking antibody, for the treatment of unresectable HCC and, in some cases, with platinum-based chemotherapy for metastatic NSCLC. This approval was based on clinical trials such as the HIMALAYA and POSEIDON studies, which demonstrated significant benefits in terms of progression-free survival (PFS) and overall survival (OS)[4][5].

Market Positioning

Imjudo, in combination with Imfinzi, enters a competitive market for immunotherapies targeting various types of cancer. The combination of a CTLA-4 and a PD-L1 inhibitor is a strategic approach to enhance antitumor immune responses, positioning Imjudo as a viable option for patients with advanced HCC and NSCLC[4].

Clinical Trials and Efficacy

The HIMALAYA study showed that a single dose of tremelimumab-actl followed by durvalumab significantly improved OS rates in patients with unresectable HCC. The POSEIDON trial demonstrated the efficacy of the combination of tremelimumab-actl, durvalumab, and platinum-based chemotherapy in patients with metastatic NSCLC, highlighting improved PFS and OS rates[4].

Cost-Effectiveness and Pricing

The cost-effectiveness of Imjudo in combination with Imfinzi is a critical factor in its market dynamics. According to Health Canada, the incremental cost-effectiveness ratio (ICER) for this combination compared to sorafenib was $265,036 per quality-adjusted life-year (QALY) gained, which is not cost-effective at a willingness-to-pay threshold of $50,000 per QALY. This suggests that a price reduction may be necessary for the combination to be considered cost-effective[1].

Budget Impact and Uncertainty

The budget impact analysis revealed discrepancies between the sponsor's estimates and those of the Canadian Agency for Drugs and Technologies in Health (CADTH). Key uncertainties included the overestimation of patients with BCLC stage C disease at diagnosis and the assumption of continued treatment after disease progression, which clinical experts indicated is not typical. These uncertainties need to be addressed during price negotiations and implementation[1].

Financial Performance of AstraZeneca

AstraZeneca's financial performance has been robust, with total revenue increasing by 60% in Q1 2022, driven by growth across various segments. However, the revenue from COVID-19 medicines is expected to decline, while sales of other medicines, including those like Imjudo, are anticipated to contribute to the company's growth. The integration of Alexion expenses and the impact of pricing programs in emerging markets are also significant factors in AstraZeneca's financial outlook[3].

Market Opportunity

The approval of Imjudo opens up a significant market opportunity for AstraZeneca, particularly in the treatment of HCC and NSCLC. Given the prevalence of these cancers and the limited treatment options available, the combination therapy of Imjudo and Imfinzi is poised to capture a substantial share of the immunotherapy market.

Competitive Landscape

The immunotherapy market is highly competitive, with several other checkpoint inhibitors available. However, the unique combination of a CTLA-4 and a PD-L1 inhibitor sets Imjudo apart, offering a differentiated treatment option for patients. The clinical trial data supporting its efficacy will be crucial in competing with other established therapies.

Regulatory Environment

Regulatory approvals and pricing decisions significantly influence the market dynamics of Imjudo. The FDA approval and subsequent reviews by health authorities in other countries will determine the drug's accessibility and affordability. The recent ruling on 340B hospital reimbursement rates, for instance, can impact the drug's pricing and accessibility in the US market[2].

Patient Access and Affordability

Patient access and affordability are critical factors in the market success of Imjudo. Given the high ICER and the need for a price reduction to be considered cost-effective, AstraZeneca may need to negotiate with health authorities and payers to ensure that the drug is accessible to patients who need it.

Future Outlook

The future outlook for Imjudo is promising, given its clinical efficacy and the growing demand for immunotherapies. However, navigating the complexities of cost-effectiveness, pricing, and regulatory environments will be essential for its market success. AstraZeneca's continued investment in research and development, as well as its strategic pricing and access strategies, will be key to maximizing the drug's market potential.

Conclusion

Tremelimumab-actl (Imjudo) represents a significant advancement in the treatment of unresectable HCC and metastatic NSCLC. While its clinical efficacy is well-documented, the financial trajectory and market dynamics are influenced by factors such as cost-effectiveness, pricing, and regulatory approvals. Addressing these challenges will be crucial for ensuring patient access and maximizing the drug's market potential.

Key Takeaways

• FDA Approval: Imjudo is approved for the treatment of unresectable HCC and metastatic NSCLC in combination with other therapies.
• Clinical Efficacy: The drug has shown significant benefits in PFS and OS rates in clinical trials.
• Cost-Effectiveness: The combination is not cost-effective at current prices and may require a price reduction.
• Market Opportunity: The drug has a significant market opportunity in the immunotherapy segment.
• Regulatory Environment: Regulatory approvals and pricing decisions are critical for market success.
• Patient Access: Ensuring affordability and access will be essential for the drug's success.

FAQs

Q: What is the FDA-approved indication for tremelimumab-actl (Imjudo)? A: Imjudo is approved for the treatment of adult patients with unresectable hepatocellular carcinoma (HCC) and metastatic non-small cell lung cancer (NSCLC) in combination with other therapies[4][5].

Q: How does the combination of Imjudo and Imfinzi work? A: The combination works by blocking CTLA-4 and PD-L1 pathways, enhancing antitumor immune responses[4].

Q: What are the key clinical trials supporting the approval of Imjudo? A: The HIMALAYA and POSEIDON trials demonstrated the efficacy of Imjudo in combination with Imfinzi and platinum-based chemotherapy[4].

Q: Is the combination of Imjudo and Imfinzi cost-effective? A: Currently, the combination is not cost-effective at a willingness-to-pay threshold of $50,000 per QALY gained and may require a price reduction[1].

Q: What are the future prospects for Imjudo in the market? A: The future outlook is promising due to its clinical efficacy, but navigating cost-effectiveness, pricing, and regulatory environments will be crucial for its market success.

Sources

1. Health Canada Indication for Tremelimumab in Combination with Durvalumab. NCBI Books.
2. Clinical Insights: October 26, 2022. RxStrategies.
3. Q1 2022 Results Announcement. AstraZeneca PLC.
4. IMJUDO (Tremelimumab-actl) in Combination With IMFINZI (Durvalumab) Receives FDA Approval for HCC and NSCLC. AHDB Online.
5. Tremelimumab-actl. National Cancer Institute.

Last updated: 2024-12-21