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Use of anti-CEACAM5 immunoconjugates for treatment of lung cancer

An immunoconjugate and application technology, applied in the direction of anti-animal/human immunoglobulin, immunoglobulin, antibody medical components, etc.

Pending Publication Date: 2022-03-11
SANOFI SA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although a variety of therapies have been used to treat individuals with lung cancer, more effective treatments are needed

Method used

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  • Use of anti-CEACAM5 immunoconjugates for treatment of lung cancer
  • Use of anti-CEACAM5 immunoconjugates for treatment of lung cancer
  • Use of anti-CEACAM5 immunoconjugates for treatment of lung cancer

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0321] Example 1: TED13751 - First-in-human study to evaluate the safety, pharmacokinetics and antitumor activity of huMAb2-3-SPDB-DM4 in patients with advanced solid tumors - study design

[0322] A first-in-human (FIH) clinical study to evaluate the safety and pharmacokinetics of an ADC identified as huMAb2-3-SPDB-DM4 administered as a single agent by the intravenous route every 2 weeks (q2w; 14 days) at In adults with advanced, unresectable, or metastatic solid tumors.

[0323] The study is divided into two parts: an incremental phase and an expansion phase.

[0324] During the incremental phase, the population to be treated was enriched for patients with tumor types known to express CEACAM5 but not limited; CEACAM5 expression was confirmed retrospectively in a central laboratory using IHC on recent archival tissue samples. Expression of circulating CEACAM5 was also used for enrichment. During the escalation phase, a maximum tolerated dose (MTD) of 100 mg / m was determin...

Embodiment 2

[0392] Example 2 : TED13751 - Expansion Phase - NSQ NSCLC Cohort - Primary Phase Interim Analysis

[0393] As discussed in Example 1, there were two separate cohorts in the expansion stage of non-sqNSCLC based on assessment of local or central CEACAM5 expression on archival tumor tissue: the first cohort included CEACAM5 expression of intensity ≥2+ involving at least 50 % of tumor cell population in patients. A second independent cohort (lung bis) included patients who pre-screened positive with a strength of >2+ in 21% to 2 huMAb2-3-SPDB-DM4 treatment.

[0394] Include a minimum of 30 patients pretreated with anti-PD1 / anti-PDL1 for the NSQ NSCLC (lung) cohort of tumor cell populations with CEACAM5 expression ≥50% of intensity ≥2+ to evaluate in patients pretreated with anti-PDL1 Antitumor activity of huMAb2-3-SPDB-DM4, and the minimum ability to ensure subgroup analysis in this subpopulation. For the NSQ NSCLC (lung bis) cohort with CEACAM5 expression between ≥1% and 2+ i...

Embodiment 3

[0415] Example 3 : TED13751 - Expansion Phase - NSQ NSCLC High Expressor Cohort - Primary Phase Complete Cohort Analysis of 32 Patients Treated

[0416] A complete analysis of the cohort of 32 patients confirmed the interim analysis of Example 2.

[0417] It was shown to promote antitumor activity in CEACAM5 ≥ 50% of overpretreated patients with NSQ NSCLC. This antitumor activity was associated with a 25% response rate (90% CI 14.70-39.20%) according to RECIST 1.1.

[0418] As shown in Table 7, an objective response of 25% was observed in the 32 patients treated in the high CEACAM5 expression (lung) cohort.

[0419] Table 7: Best objective response among 32 patients treated in the high CEACAM5 expression (lung) cohort.

[0420]

[0421] Furthermore, as shown in Figure 3, the best relative tumor shrinkage was generally observed in patients with CEACAM5 expression of 50%-80% or greater. As shown in Figure 4, time to progression (TTP) was also improved in the high expre...

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Abstract

The present disclosure provides methods of treating cancers with high CEACAM5 expression, including lung cancers such as NSQ NSCLC, using immunoconjugates comprising antibodies that specifically bind to human CEACAM5.

Description

technical field [0001] The present disclosure relates to the therapeutic treatment of CEACAM5 expressing cancers such as non-squamous non-small cell lung cancer (NSQ NSCLC). Certain aspects of the invention relate to the use of CEACAM5 antagonists, such as anti-CEACAM5 antibodies and immunoconjugates, for the treatment of lung cancer. Background technique [0002] The mechanism of action of antibody-drug conjugates (ADCs) begins with their binding to specific antigens well expressed on tumor cells to achieve selective and efficient internalization of the drug. The use of ADCs to selectively target potent cytotoxins to tumor cells has been shown to be an effective strategy for the treatment of cancer, as seen through the recent approval of Vitin-Bentuximab for Hodgkin's Lymphoma and Emmet-Trizumab. Tocilizumab (T-DM1) was used to treat recurrent metastatic HER2+ breast cancer. Many other malignancies such as solid tumor cancers with unmet medical needs may benefit from such...

Claims

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Application Information

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IPC IPC(8): A61K47/68A61P35/00C07K16/30
CPCA61P35/00C07K16/30A61K47/6803A61K47/6853A61K2039/545A61K2039/505A61K45/06C07K16/2818C07K16/2827C07K16/3023
Inventor A·阿拉德M·卡德加C·科姆博B·德默斯C·亨利S·约克
Owner SANOFI SA
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