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Weekly Top News – Breast Cancer – June 17, 2019

June 17, 2019

Ibrance (palbociclib) / Pfizer
Ibrance clinical trial estimate: Data from P3 PALLAS trial (NCT02513394) for HR+/HER2- breast cancer in late 2020 (Morgan Stanley) – Jun 13, 2019 – A subscription to Thomson ONE is required to gain full access to report 67445936; Page no: 10; REPORT TITLE: “Pfizer: Resuming at overweight ahead of accelerating growth”; AUTHOR: Risinger, David, et al; DATE: 06/04/2019

 

Ibrance (palbociclib) / Pfizer
Ibrance clinical trial estimate: Data from P3 PENELOPE-B trial (NCT01864746) for breast cancer in late 2020 (Morgan Stanley) – Jun 13, 2019 – A subscription to Thomson ONE is required to gain full access to report 67445936; Page no: 10; REPORT TITLE: “Pfizer: Resuming at overweight ahead of accelerating growth”; AUTHOR: Risinger, David, et al; DATE: 06/04/2019

 

[fam-] trastuzumab deruxtecan (DS-8201) / Daiichi Sankyo
DS-8201: BLA submission for HER2 positive metastatic breast cancer previously treated with T-DM1 (based on DESTINY-Breast01 trial) in H1 FY2019 (Daiichi Sankyo) – Jun 13, 2019 – ASCO 2019: NDA submission in Japan for HER2 positive gastric cancer (based on DESTINY-Gastric01 trial) in H1 FY2020 
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Herceptin (trastuzumab) / Roche; pyrotinib (HTI-1001) / Jiangsu Hengrui Medicine
A Study of Evaluating The Effects Of Pyrotinib After Adjuvant Trastuzumab In Women With Early Stage Breast Cancer (clinicaltrials.gov) – Jun 11, 2019 – P3; N=1192; Not yet recruiting; Sponsor: Jiangsu HengRui Medicine Co., Ltd.

 

Kanjinti (trastuzumab biosimilar) / Amgen, Daiichi Sankyo, Allergan
FDA approves Amgen and Allergan’s Kanjinti (trastuzumab-anns), a biosimilar to Herceptin (trastuzumab) (PRNewswire) – Jun 13, 2019 – “Amgen (NASDAQ:AMGN) and Allergan plc (NYSE:AGN) today announced that the U.S. Food and Drug Administration (FDA) has approved KANJINTI™ (trastuzumab-anns) for all approved indications of the reference product, Herceptin® (trastuzumab): for the treatment of HER2-overexpressing adjuvant and metastatic breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma…Approval based on totality of evidence demonstrating Kanjinti is biosimilar to Herceptin.”

 

Ibrance (palbociclib) / Pfizer
Palbociclib Plus Letrozole For Postmenopausal Women With HR(+) HER2(-) Advanced Breast Cancer For Whom Letrozole Is Deemed Appropriate (clinicaltrials.gov) – Jun 14, 2019 – P3; N=131; Completed; Sponsor: Pfizer; Active, not recruiting –> Completed

 

Ibrance (palbociclib) / Pfizer
Ibrance clinical trial estimate: Primary completion of P3 PENELOPE-B trial (NCT01864746) for breast cancer in December 2020 and final completion of trial in November 2023 (Morgan Stanley) – Jun 13, 2019 – A subscription to Thomson ONE is required to gain full access to report 67445936; Page no: 10; REPORT TITLE: “Pfizer: Resuming at overweight ahead of accelerating growth”; AUTHOR: Risinger, David, et al; DATE: 06/04/2019

 

Kisqali (ribociclib) / Novartis; Afinitor (everolimus) / Novartis
Triplet therapy confers benefit among certain patients with advanced breast cancer (Healio) – Jun 13, 2019 – P1/2, N=107; TRINITI-1 (NCT02732119); Sponsor: Novartis Pharmaceuticals; ‘”Preclinical evidence suggests that the addition of everolimus (an mTOR inhibitor) to ribociclib (a CDK4/6 inhibitor) and exemestane (an aromatase inhibitor) may restore sensitivity to both CDK4/6 inhibitor and endocrine-based therapy,’ Aditya Bardia, MD, MPH…told HemOnc Today….Ninety-five patients (median age, 58 years; 81% white) who were refractory to endocrine-based therapy and progressed after receiving CDK4/6 inhibitors were evaluable as of Oct. 24, 2018…The triplet therapy [everolimus, ribociclib and exemestane] demonstrated a clinical benefit rate of 41.1% (95% CI, 31.1-51.5) at 24 weeks, which was four times the minimum threshold for the study. The disease control rate was 61.1% (95% CI, 50.7-70.9), and the overall response rate was 8.4% (95% CI, 3.7-15.9), including one complete response and seven partial responses. Median PFS was 5.7 months (95% CI, 3.6-9.1), with a 1-year…

 

Ibrance (palbociclib) / Pfizer
Ibrance clinical trial estimate: Primary completion of P3 PALLAS trial (NCT02513394) for HR+/HER2- breast cancer in September 2020 and final completion of trial in September 2025(Morgan Stanley) – Jun 13, 2019 – A subscription to Thomson ONE is required to gain full access to report 67445936; Page no: 10; REPORT TITLE: “Pfizer: Resuming at overweight ahead of accelerating growth”; AUTHOR: Risinger, David, et al; DATE: 06/04/2019

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