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Endocyte Announces FDA's Acceptance of Trial Endpoint Change
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Endocyte, Inc. recently announced that the FDA has accepted radiographic progression free survival (rPFS) as an alternative primary endpoint for the ongoing phase III trial, VISION. The development should support the submission of a New Drug Application (NDA) for full FDA approval of 177Lu-PSMA-617 for the treatment of metastatic castration-resistant prostate cancer (mCRPC).
177Lu-PSMA-617, a prostate specific membrane antigen (PSMA)-targeted radioligand therapy, is Endocyte’s lead program. It is being evaluated in a phase III study for mCRPC for PSMA-positive patients.
The decision was taken during the company’s meeting with the FDA. This new endpoint is in addition to overall survival (OS) endpoint. Per the company, this should expedite the likelihood of a full approval sooner than the previous expectation. A positive assessment on either rPFS or OS will be sufficient for full approval.
Endocyte now expects the analysis of rPFS for potential full approval to occur before the end of 2019. Final and full OS analysis is expected by the end of 2020.
Per the updated design of the trial, the two interim assessments previously planned at 50% and 70% of OS events will now be replaced with a single assessment of rPFS.
The trial will enroll up to 750 patients worldwide with PSMA-positive scans, randomized in a 2:1 ratio to receive 177Lu-PSMA-617 along with best supportive/best standard of care compared to best supportive/best standard of care alone.
The single assessment will take place at the same time as the first interim OS assessment would have occurred under the prior trial design and shortly after the trial is fully enrolled.
Assuming the candidate meets the primary endpoint in the rPFS assessment without any safety issues and demonstrates no detriment in OS relative to the control arm, Endocyte intends to submit an NDA to seek full approval in the United States. The rPFS analysis will include approximately 450 rPFS events.
Meanwhile, Endocyte plans to follow patients in the VISION trial for the assessment of the final OS alternative primary endpoint irrespective of the outcome of the rPFS assessment. However, the other aspects of the trial including patient treatment and assessments, trial size, overall duration and follow up remain unchanged.
Endocyte will also discuss the same for a full approval in Europe.
A tentative approval will boost Endocyte’s growth prospects significantly. Year to date, Endocyte’s shares have rallied 335.1% against the industry’s decline of 0.1%.
Apart from the lead candidate, Endocyte expects to have an Investigational New Drug application submitted in the fourth quarter of 2018 for its adaptor-controlled CAR T-cell therapy, which will be studied initially in osteosarcoma.
Zacks Rank & Key picks
Endocyte currently carries a Zacks Rank #3 (Hold).
Gilead’s earnings per share estimates have increased from $6.12 to $6.58 for 2018 and from $6.36 to $6.48 for 2019 over the past 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters with an average beat of 6.43%.
Ligand’s earnings per share estimates have moved up from $4.93 to $6.33 for 2018 and from $5.39 to $5.74 for 2019 in the past 60 days. The company delivered positive earnings surprises in each of the trailing four quarters with an average beat of 59.5%.
Celgene’s earnings per share estimates have increased from $8.54 to $8.76 for 2018 and from $10.21 to $10.65 for 2019 over the past 60 days. The company delivered positive earnings surprises in all the trailing four quarters with an average beat of 2.38%.
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Zacks names 5 companies poised to ride a medical breakthrough that is targeting cures for leukemia, AIDS, muscular dystrophy, hemophilia, and other conditions.
New products in this field are already generating substantial revenue and even more wondrous treatments are in the pipeline. Early investors could realize exceptional profits.
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Endocyte Announces FDA's Acceptance of Trial Endpoint Change
Endocyte, Inc. recently announced that the FDA has accepted radiographic progression free survival (rPFS) as an alternative primary endpoint for the ongoing phase III trial, VISION. The development should support the submission of a New Drug Application (NDA) for full FDA approval of 177Lu-PSMA-617 for the treatment of metastatic castration-resistant prostate cancer (mCRPC).
177Lu-PSMA-617, a prostate specific membrane antigen (PSMA)-targeted radioligand therapy, is Endocyte’s lead program. It is being evaluated in a phase III study for mCRPC for PSMA-positive patients.
The decision was taken during the company’s meeting with the FDA. This new endpoint is in addition to overall survival (OS) endpoint. Per the company, this should expedite the likelihood of a full approval sooner than the previous expectation. A positive assessment on either rPFS or OS will be sufficient for full approval.
Endocyte now expects the analysis of rPFS for potential full approval to occur before the end of 2019. Final and full OS analysis is expected by the end of 2020.
Per the updated design of the trial, the two interim assessments previously planned at 50% and 70% of OS events will now be replaced with a single assessment of rPFS.
The trial will enroll up to 750 patients worldwide with PSMA-positive scans, randomized in a 2:1 ratio to receive 177Lu-PSMA-617 along with best supportive/best standard of care compared to best supportive/best standard of care alone.
The single assessment will take place at the same time as the first interim OS assessment would have occurred under the prior trial design and shortly after the trial is fully enrolled.
Assuming the candidate meets the primary endpoint in the rPFS assessment without any safety issues and demonstrates no detriment in OS relative to the control arm, Endocyte intends to submit an NDA to seek full approval in the United States. The rPFS analysis will include approximately 450 rPFS events.
Meanwhile, Endocyte plans to follow patients in the VISION trial for the assessment of the final OS alternative primary endpoint irrespective of the outcome of the rPFS assessment. However, the other aspects of the trial including patient treatment and assessments, trial size, overall duration and follow up remain unchanged.
Endocyte will also discuss the same for a full approval in Europe.
A tentative approval will boost Endocyte’s growth prospects significantly. Year to date, Endocyte’s shares have rallied 335.1% against the industry’s decline of 0.1%.
Apart from the lead candidate, Endocyte expects to have an Investigational New Drug application submitted in the fourth quarter of 2018 for its adaptor-controlled CAR T-cell therapy, which will be studied initially in osteosarcoma.
Zacks Rank & Key picks
Endocyte currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Gilead Sciences Inc. (GILD - Free Report) , Ligand Pharmaceuticals Inc. (LGND - Free Report) and Celgene Corp. . While Gilead and Ligand sport a Zacks Rank #1 (Strong Buy), Celgene carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Gilead’s earnings per share estimates have increased from $6.12 to $6.58 for 2018 and from $6.36 to $6.48 for 2019 over the past 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters with an average beat of 6.43%.
Ligand’s earnings per share estimates have moved up from $4.93 to $6.33 for 2018 and from $5.39 to $5.74 for 2019 in the past 60 days. The company delivered positive earnings surprises in each of the trailing four quarters with an average beat of 59.5%.
Celgene’s earnings per share estimates have increased from $8.54 to $8.76 for 2018 and from $10.21 to $10.65 for 2019 over the past 60 days. The company delivered positive earnings surprises in all the trailing four quarters with an average beat of 2.38%.
5 Medical Stocks to Buy Now
Zacks names 5 companies poised to ride a medical breakthrough that is targeting cures for leukemia, AIDS, muscular dystrophy, hemophilia, and other conditions.
New products in this field are already generating substantial revenue and even more wondrous treatments are in the pipeline. Early investors could realize exceptional profits.
Click here to see the 5 stocks >>