Tedopi Phase 2 : results

Positive results from a Phase 2 study with Tedopi® have enabled the company to initiate the ongoing Atalante 1 Phase 3 study on non-small cell lung cancer (NSCLC).

Phase 2 clinical trials – Protocol and results

A Phase 2 study conducted in the U.S. in patients with non-small cell lung cancer (NSCLC) has proven the good safety and efficacy of the treatment.

The median survival of patients treated with Tedopi® was 17.3 months, versus 12 months for the control group of HLA-A2 negative patients. With existing second line therapies, the median survival of such patients ranges from five to eight months*.

The results have also shown a one-year survival rate of 59% compared with 33%** for currently available treatments, the one-year survival rate is.

*Source: median survival with existing second line treatment
**Source: survival rate after 1 year with existing second line treatment

Tedopi®

Recommended in case of the failure of at least one first line therapy
Results
– Improvement in one-year survival rate
• Patients treated with Tedopi® :
59% of survival
• Control group (HLA-A2-): 
49% of survival 

– Improvement in median survival
• Patients treated with Tedopi ® : 17.3 months 
• Control group (HLA-A2-): 
12 months

– Improvement in long-term survival rate of patients treated with Tedopi®:
• Global four-year rate: 
25%

Efficacy in patients with invasive or metastatic NSCLC heavily pretreated, with 89% having showed a stabilization of their disease. 

Strong correlation between immune T response and survival: longer survival interrelated with the number of positive responses to epitopes.

Design of the study
135 patients, with advanced lung cancer at invasive stage IIIB or metastatic stage IV:

– 64 HLA-A2 positive patients were treated with Tedopi®
• Median age: 64 years old
• 55% male patients
• 67% metastatic cancers: 21 at invasive stage IIIb, 43 at metastatic stage IV
• 65.5% received more than two previous treatment lines
• 92% received a standard treatment with platinum

– Control group: 72 HLA-A2 negative patients
• Median age: 65 years old
• 51 were male patients

Primary endpoint
Global survival and tolerance
Secondary endpoint
– Evolution of the disease (tumor progression, stabilization or decline)
– T cytotoxic immune response (Elispot)
Fulfillment of the study
The product was administered to HLA-A2 positive patients subcutaneously every other 3 weeks for the first six injections, and then every other 2 or 3 months during the first year.

An amendment was been presented (approved ?) to treat these patients for another year, with an injection every other 3 months, for a total of 13 subcutaneous injections.
Follow-up care occurred every other 3 months until the 3rd year at the beginning of the treatment at week 9 and 18 then at months 6, 9 and 12.

Principal investigator
John Nemunaitis, MCCR Dallas

Currently, the median survival for the three treatments recorded as second line therapies (docetaxel, pemetrexed and erlotinib) ranges from five to eight months and the one-year survival rate is 33%.
The median survival of 17.3 months reached by the group treated with Tedopi® is substantial, especially given that 67% of the patients in this trial were at a metastatic stage.
Publications :
The data and the results of the studies conducted by OSE Pharma have appeared in many scientific publications, including specialized journals, accessible via link below.
See the publications