Advanced Accelerator Applications Reports New England Journal of Medicine Publication of Lutathera NETTER-1 Phase III Results
Benzinga 9 years ago
News
Advanced Accelerator Applications S.A. (NASDAQ: AAAP) (“AAA” or “the Company”), an international specialist in Molecular Nuclear Medicine (MNM), today announced that the New England Journal of Medicine published the results of the NETTER-1 Phase III study evaluating efficacy and safety of Lutathera® (lutetium-177 dotatate), an investigational drug, in patients with advanced, progressive somatostatin receptor-positive midgut neuroendocrine tumors (“NETs”).
In this study, the primary endpoint was progression-free survival (PFS). Secondary endpoints included objective response rate (ORR), overall survival, safety, and tolerability. The NETTER-1 study met its primary endpoint by demonstrating that treatment with Lutathera® was associated with a statistically significant and clinically meaningful 79% reduction in risk of disease progression or death versus treatment with a high dose (60 mg) of Octreotide LAR (hazard ratio 0.21, 95% Confidence Interval: 0.13-0.33; p<0.0001). The estimated PFS rate at month 20 was 65.2% (95% Confidence Interval: 50.0-76.8) in the Lutathera® arm and 10.8% (95% Confidence Interval: 3.5-23.0) in the control arm. Median PFS was 8.4 months in the control arm, and had not yet been reached in the Lutathera® arm.
Significant treatment benefits associated with Lutathera® were observed irrespective of stratification factors and prognostic factors. The response rate of 18% in the Lutathera® arm (compared to 3% with Octreotide) is also notable given that response rates above 5% have not been observed in large randomized clinical trials investigating other systemic therapies in this population. Although the trial has not reached the point at which median overall survival can be calculated, interim analysis suggests an overall survival improvement. Importantly, Lutathera® when administered concomitantly with a renal-protective agent, had low rates of grade three or four hematological toxicity, and no evidence of nephrotoxicity observed over the study time-frame (median follow-up time 14 months).
Jonathan Strosberg, MD, Associate Professor, Section Head, Neuroendocrine Tumor Program at Moffitt Cancer Center, and lead author of the publication noted, “The clinically meaningful and statistically significant improvement in PFS and ORR achieved with treatment of Lutathera®, when compared to high dose Octreotide supports its potential utility in the treatment of NET patients. As a clinician treating many patients with this condition, these results bring hope for our ability to improve lives.”
Stefano Buono, Chief Executive Officer of AAA stated, “We believe these data show significant clinical benefit of Lutathera® and are proud to have this study published in such a prestigious journal. More than 1,500 patients in the U.S. and Europe have received treatment with Lutathera® through our compassionate use and named patient programs. We believe Lutathera® can offer patients with NETs a much needed treatment option and enhance the current standard of care.”
The New England Journal of Medicine publication may be found online at: http://www.nejm.org/doi/full/10.1056/NEJMoa1607427.
In this study, the primary endpoint was progression-free survival (PFS). Secondary endpoints included objective response rate (ORR), overall survival, safety, and tolerability. The NETTER-1 study met its primary endpoint by demonstrating that treatment with Lutathera® was associated with a statistically significant and clinically meaningful 79% reduction in risk of disease progression or death versus treatment with a high dose (60 mg) of Octreotide LAR (hazard ratio 0.21, 95% Confidence Interval: 0.13-0.33; p<0.0001). The estimated PFS rate at month 20 was 65.2% (95% Confidence Interval: 50.0-76.8) in the Lutathera® arm and 10.8% (95% Confidence Interval: 3.5-23.0) in the control arm. Median PFS was 8.4 months in the control arm, and had not yet been reached in the Lutathera® arm.
Significant treatment benefits associated with Lutathera® were observed irrespective of stratification factors and prognostic factors. The response rate of 18% in the Lutathera® arm (compared to 3% with Octreotide) is also notable given that response rates above 5% have not been observed in large randomized clinical trials investigating other systemic therapies in this population. Although the trial has not reached the point at which median overall survival can be calculated, interim analysis suggests an overall survival improvement. Importantly, Lutathera® when administered concomitantly with a renal-protective agent, had low rates of grade three or four hematological toxicity, and no evidence of nephrotoxicity observed over the study time-frame (median follow-up time 14 months).
Jonathan Strosberg, MD, Associate Professor, Section Head, Neuroendocrine Tumor Program at Moffitt Cancer Center, and lead author of the publication noted, “The clinically meaningful and statistically significant improvement in PFS and ORR achieved with treatment of Lutathera®, when compared to high dose Octreotide supports its potential utility in the treatment of NET patients. As a clinician treating many patients with this condition, these results bring hope for our ability to improve lives.”
Stefano Buono, Chief Executive Officer of AAA stated, “We believe these data show significant clinical benefit of Lutathera® and are proud to have this study published in such a prestigious journal. More than 1,500 patients in the U.S. and Europe have received treatment with Lutathera® through our compassionate use and named patient programs. We believe Lutathera® can offer patients with NETs a much needed treatment option and enhance the current standard of care.”
The New England Journal of Medicine publication may be found online at: http://www.nejm.org/doi/full/10.1056/NEJMoa1607427.