Weekly Top News – Breast Cancer – May 6, 2019

May 6, 2019

Tecentriq (atezolizumab) / Roche
Tecentriq clinical trial estimate: Updated OS data from P3 IMpassion031 trial (NCT03197935) for TNBC at ASCO 2019 (May 31 – June 4, 2019) (Cantor Fitzgerald) – May 3, 2019 – A subscription to Thomson ONE is required to gain full access to report 67171383; Page no: 1; REPORT TITLE: “Cantor daily research highlights”; AUTHOR: Research Department, et al; DATE: 04/24/2019


Tecentriq (atezolizumab) / Roche
GeparDouze/NSABP B-59: A randomized double-blind phase III clinical trial of neoadjuvant chemotherapy with atezolizumab or placebo in patients with triple negative breast cancer (TNBC) followed by adjuvant atezolizumab or placebo (ESMO-BC 2019) – May 5, 2019 – Abstract #122TiP; Pres time: May 3, 2019; 12:15 PM – 01:00 PM; Location: Exhibition area; P3; “…Accrual will be 1,520 randomized patients stratified by region (North America; Europe), tumor size (1.1-3.0 cm; > 3.0 cm), epirubicin or doxorubicin/cyclophosphamide (EC; AC) schedule (q2w; q3w), and nodal status (positive; negative). Patients are randomized 1:1 to receive atezolizumab 1200 mg or placebo IV every 3 weeks concurrently with sequential regimens of weekly paclitaxel 80 mg/m2 IV for 12 doses and every 3 week carboplatin AUC of 5 IV for 4 doses followed by AC/EC every 2-3 weeks (per investigator discretion) for 4 cycles…Main secondary endpoints include pCR breast, overall survival, distant disease-free survival, safety and toxicity. GeparDouze is performed as an academic collaboration between NSABP and GBG.”


Ibrance (palbociclib) / Pfizer
Ibrance: Data from P3 PALLAS trial (NCT02513394) for HR+/HER2- breast cancer in H2 2020 (Pfizer) – Apr 30, 2019 – Q1 2019 Results: Data from P3 PENELOPE-B trial (NCT01864746) for breast cancer in H2 2020


Keytruda (pembrolizumab) / Merck (MSD)
Keytruda: Data from P3 KEYNOTE-522 trial (NCT03036488) for TNBC in 2019 (Merck (MSD)) – Apr 30, 2019 – Q1 2019 Results: Data from P3 KEYNOTE-355 trial (NCT02819518) for 1L TNBC in 2019


Talzenna (talazoparib) / Pfizer
Impact of objective response (OR) on patient-reported outcomes (PRO) in patients (pts) with advanced breast cancer (ABC) and a germline BRCA1/2 (gBRCA) mutation in the phase III EMBRACA trial (ESMO-BC 2019) – May 5, 2019 – Abstract #154O; Pres time: May 2, 2019; 05:20 PM – 05:25 PM; Location: Vienna Hall; “…Background: In EMBRACA, a randomised 2:1 phase 3 open-label study of pts with ABC and a gBRCA mutation, a statistically significant higher OR rate was observed with talazoparib (TALA) (n = 219) vs physician’s choice of chemotherapy (PCT; n = 114) (62.6% vs 27.2%; odds ratio, 5.0; 95% CI, 2.9, 8.8; P < 0.001)… Overall change from baseline and greater delay in TTD in GHS/QoL were observed favouring pts who experienced OR vs those who did not have OR. These results suggest that higher OR rates may lead to better overall improvement from baseline and greater delay in TTD in GHS/QoL in pts with ABC and a gBRCA mutation.”


Kadcyla (ado-trastuzumab emtansine) / Roche
FDA approves Genentech’s Kadcyla for adjuvant treatment of people with HER2-positive early breast cancer with residual invasive disease after neoadjuvant treatment (Roche Press Release) – May 3, 2019 – “Genentech…announced that the U.S. Food and Drug Administration (FDA) has approved Kadcyla® (ado-trastuzumab emtansine) for adjuvant (after surgery) treatment of people with HER2-positive early breast cancer (EBC) who have residual invasive disease after neoadjuvant (before surgery) taxane and Herceptin® (trastuzumab)-based treatment…The FDA rapidly reviewed and approved the application under the FDA’s Real-Time Oncology Review (RTOR) and Assessment Aid pilot programs…This approval is based on results of the Phase III KATHERINE study…”


Verzenio (abemaciclib) / Eli Lilly
Verzenio: Data from P2 monarcHER trial (NCT02675231) in metastatic breast cancer at the end of 2019 (Eli Lilly) – May 1, 2019 – Q1 2019 Results


capecitabine / generics; Avastin (bevacizumab) / Roche
Continuous chemotherapy improves outcomes and quality of life in advanced breast cancer [ESMO press release] (ESMO.org) – Apr 30, 2019 – P3, N=420; Stop&Go (NCT01935492); “The phase III study randomised 420 patients with advanced HER2-negative breast cancer to either an intermittent schedule (four cycles – ‘treatment holiday’ – another four cycles) or a continuous schedule comprised of the same eight cycles administered consecutively. Both first line treatment (paclitaxel plus bevacizumab) and second line treatment (capecitabine or non-pegylated liposomal doxorubicin) followed these schedules….Patients who started second line treatment (n=270; 131 vs. 139 in intermittent vs. continuous arms) demonstrated a median PFS in second line of 3.5 vs. 5.0 months respectively, with a hazard ratio (HR) of 1.04 (95%CI 0.69-1.57).”


Tecentriq (atezolizumab) / Roche
IMpassion031: A Study to Investigate Atezolizumab and Chemotherapy Compared With Placebo and Chemotherapy in the Neoadjuvant Setting in Participants With Early Stage Triple Negative Breast Cancer (clinicaltrials.gov) – Apr 29, 2019 – P3; N=324; Recruiting; Sponsor: Hoffmann-La Roche; Active, not recruiting –> Recruiting; N=204 –> 324; Trial completion date: Sep 2021 –> Jan 2023; Trial primary completion date: Mar 2019 –> Sep 2020


Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
A pragmatic, randomised, multicentre trial comparing 4-weekly vs. 12-weekly administration of bone-targeted agents (denosumab, zoledronate or pamidronate) in patients with bone metastases (ESMO-BC 2019) – May 5, 2019 – Abstract #LBA3; Pres time: May 2, 2019; 04:30 PM – 04:35 PM; Location: Vienna Hall; P4; “The findings of this trial are consistent with those previously reported for de-escalating ZA. This trial also included pts receiving de-escalated DN and PAM. While the results of the REDUSE trial are awaited, the data presented would suggest that de-escalation of commonly used BTAs is a reasonable treatment option.”

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