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PHAXIAM ERYTECH Announces Results from TRYbeCA - 1 Phase 3 Trial of Eryaspase in Patients with Second - line Advanced Pancreatic Cancer Oct 25 , 2021 | Press Releases ERYTECH Announces Results from TRYbeCA - 1 Phase 3 Trial of Eryaspase in Patients with Second - line Advanced Pancreatic Cancer Management to host Conference Call on Monday , October 25 , at 8:30 am EDT / 2:30 pm CEST ■ The trial did not meet its primary endpoint of overall survival ■ The prespecified subgroup of patients treated with eryaspase and an irinotecan - based chemotherapy demonstrated an interesting trend of survival benefit , which merits further investigation ■ Patients treated with eryaspase demonstrated superior disease control compared to patients treated with chemotherapy only . Other secondary endpoints showed nominal improvement ■ The safety profile of eryaspase was consistent with earlier clinical trials results and safety reviews ■ ERYTECH will now focus on its late - stage program in hypersensitive ALL and confirms its intention to submit a BLA before the end of the year ■ ERYTECH will review strategic and partnering alternatives , including for the further development and commercialization of eryaspase Cambridge , MA ( U.S. ) and Lyon ( France ) , October 25 , 2021 - ERYTECH Pharma ( Nasdaq & Euronext : ERYP ) , a clinical - stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells , today announced top - line results from its Phase 3 TRYbeCA - 1 clinical trial evaluating eryaspase as second - line treatment in 512 patients with metastatic pancreatic cancer . The trial did not meet its primary endpoint of overall survival ( OS ) . In the TRYbeCA - 1 trial , eryaspase demonstrated an improvement in the primary endpoint of OS compared to chemotherapy alone with a hazard ratio ( HR ) of 0.92 ( 95 % confidence interval ( CI ) , 0.76-1.11 ) in the intent - to - treat population , and the difference was not statistically significant ( p - value 0.375 ) . The median OS for patients treated with eryaspase plus chemotherapy was 7.5 months ( 95 % CI , 6.5-8.3 ) , compared to 6.7 months ( 95 % CI , 5.4-7.5 ) for chemotherapy alone . Interestingly , while the patients treated with gemcitabine plus nabpaclitaxel did not experience a survival benefit from the addition of eryaspase , patients treated with eryaspase and an irinotecan - based chemotherapy regimen showed nominal survival benefit with a HR of 0.77 ( 95 % CI , 5.7-1.05 ) over those treated with chemotherapy alone . This prespecified subgroup had a median OS of 8.0 months in the eryaspase - treated arm versus 5.7 months in the control arm ( per protocol population ) . Key secondary endpoints of the trial , including progression - free survival , disease control rate and objective response rate , showed benefit in favor of eryaspase . The safety profile of eryaspase observed in the TRYbeCA - 1 trial was consistent with earlier observations and previous safety reviews by the trial's independent data monitoring committee ( IDMC ) . Further analysis of the data will be performed , and full results will be presented at an upcoming medical conference . ERYTECH will now focus on its late - stage program in acute lymphoblastic leukemia ( ALL ) and pursue a path to approval in hypersensitive ALL based on positive results of NOPHO - sponsored Phase 2 trial . The Company reiterates its intention to submit a BLA before the end of the year . " While the results are disappointing , we congratulate the company for a very well managed trial in this difficult disease . With a median survival of 7.5 months , ERYTECH has created a new reference standard for clinical evaluation in second line pancreatic cancer ” , said Prof. Pascal Hammel , MD , PhD , gastroenterologist - oncologist at Beaujon Hospital in Paris and co - principal investigator of the TRYbeCA - 1 trial . " I agree with Prof Hammel , and want to add that the results in the subgroup of fluoropyrimidine - based treatments are , with a median survival of 8 months , really remarkable and merit further investigation . Especially since this was also the better subgroup in the Phase 2b trial " , said Prof. Manuel Hidalgo , M.D. , Ph.D. , Weill Cornell Medicine / NewYork - Presbyterian Hospital , and co - principal investigator of the study . " Pancreatic cancer is a very challenging , heterogeneous disease , and the results of the TRYbe CA - 1 Phase 3 trial have now also encountered this significant hurdle . " said Dr Iman El Hariry , Chief Medical Officer of ERYTECH . " It is very disappointing that the clinical benefit eryaspase demonstrated in the Phase 2 trial was not confirmed ; however , the study has addressed important questions in the management of pancreatic cancer patients . I want to thank the patients , their families and healthcare providers , our vendors , as well as our colleagues at ERYTECH , who overcame many obstacles , including the COVID - 19 pandemic , to execute this important trial . Targeting the altered asparagine and glutamine metabolism of cancer cells , well established in ALL , remains an important field of development , also for the field of solid tumors . The ERYTECH team along with its clinical advisors will review the full data analyses including the secondary and exploratory endpoints and provide a more detailed update on additional subgroup analysis after these are completed " .