Trastuzumab

A pair of antibody-drug conjugate (ADC)-based breast cancer regimens are a step closer to European approval for some first-line indications.Gilead Sciences' Trodelvy (sacituzumab govitecan) secured its second first-line metastatic triple-negative breast cancer (TNBC) endorsement in Europe in the span of a month, with the EMA's Committee for Medicinal Products for Human Use (CHMP) recommending the TROP2-directed ADC together with Merck & Co.'s Keytruda (pembrolizumab) for patients whose tumours express PD-L1."If authorised, Trodelvy plus Keytruda would build on the recent approval of Trodelvy monotherapy and help establish a Trodelvy-based approach as a first-line treatment option for patients with metastatic triple-negative breast cancer across PD-L1 status," said Evandro de Azambuja, investigator of the Phase III ASCENT-04/KEYNOTE-D19 study backing the latest recommendation.EU regulators had approved Trodelvy as a single agent last month in the frontline setting for metastatic TNBC based on data from the Phase III ASCENT-03 study, where it showed a 38% reduced risk of disease progression or death in patients who aren't candidates for PD-(L)1 inhibitors.In ASCENT-04/KEYNOTE-D19, Trodelvy plus Keytruda demonstrated a 35% lower risk of disease progression or death in patients with PD-L1–positive metastatic TNBC. In more recent data presented at this year's American Society of Clinical Oncology (ASCO) meeting, the Trodelvy-Keytruda combo led to a 33% reduction in the risk of a progression-free survival 2 (PFS2) event versus Keytruda plus chemotherapy (see – KOL Views Q&A: Breast cancer at ASCO – first take on AZ and Roche oral SERD debates, Gilead's Trodelvy TNBC data and KOL Views Q&A: Gilead’s Trodelvy poised to redefine ADC sequencing in TNBC).A nod for EnhertuCHMP also adopted a positive opinion for AstraZeneca and Daiichi Sankyo's HER2-targeting ADC Enhertu (trastuzumab deruxtecan) in combination with Roche's Perjeta (pertuzumab) as a first-line treatment for HER2-positive metastatic breast cancer.The endorsement was backed by Phase III results from the DESTINY-Breast09 trial, where Enhertu-treated patients had a 44% lower risk of disease progression or death versus the current standard of taxane, Herceptin (trastuzumab) and Perjeta. Median PFS stood at 40.7 months for the doublet and 26.9 months for the comparator group.If approved, the regimen would become the first new first-line treatment option for HER2-positive metastatic breast cancer in the EU in more than a decade, according to AstraZeneca. The regimen was greenlit in this setting by the FDA late last year.

LOS ANGELES--(BUSINESS WIRE)--Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, will host a conference call at 1:30 p.m. PT/4:30 p.m. ET on Thursday, August 6, 2026, following the release of its second quarter 2026 financial results. The call may be accessed by dialing 1-877-709-8150 (domestic) or 1-201-689-8354 (international). Please dial in at least 10 minutes in advance and inform the operator that you would like to join the “Puma Biotechnology Conference Call.” A live webcast of the conference call and presentation slides may be accessed on the Investors section of the Puma Biotechnology website at . A replay of the call will be available approximately one hour after completion of the call and will be archived on Puma’s website for 90 days. About Puma Biotechnology Puma Biotechnology, Inc. is a biopharmaceutical company with a focus on the development and commercialization of innovative products to enhance cancer care. Puma in-licensed the global development and commercialization rights to PB272 (neratinib, oral) in 2011. Neratinib, oral was approved by the U.S. Food and Drug Administration in 2017 for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, following adjuvant trastuzumab-based therapy, and is marketed in the United States as NERLYNX ® (neratinib) tablets. In February 2020, NERLYNX was also approved by the FDA in combination with capecitabine for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. NERLYNX was granted marketing authorization by the European Commission in 2018 for the extended adjuvant treatment of adult patients with early stage hormone receptor-positive HER2-overexpressed/amplified breast cancer and who are less than one year from completion of prior adjuvant trastuzumab-based therapy. NERLYNX ® is a registered trademark of Puma Biotechnology, Inc. ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); In September 2022, Puma entered into an exclusive license agreement for the development and commercialization of the anti-cancer drug alisertib, a selective, small molecule, orally administered inhibitor of aurora kinase A. Initially, Puma intends to focus the development of alisertib on the treatment of small cell lung cancer and breast cancer. In February 2024, Puma initiated ALISCA ® -Lung1, a Phase II clinical trial of alisertib monotherapy for the treatment of patients with extensive-stage small cell lung cancer. In November 2024, Puma initiated ALISCA ® -Breast1, a Phase II clinical trial of alisertib in combination with endocrine therapy for the treatment of patients with HER2-negative, HR-positive metastatic breast cancer. ALISCA ® is a registered trademark of Puma Biotechnology, Inc. Further information about Puma Biotechnology may be found at . Contacts Alan H. Auerbach or Mariann Ohanesian, Puma Biotechnology, Inc., +1 424 248 6500 info@pumabiotechnology.com ir@pumabiotechnology.com David Schull, Russo Partners, +1 212 845 4200 david.schull@russopartnersllc.com