Izalontamab Brengitecan (EGFRxHER3 ADC) Granted Breakthrough Therapy Designation by U.S. FDA for Patients with Previously Treated Advanced EGFR-Mutated Non-Small Cell Lung Cancer
Bristol Myers Squibb (NYSE: BMY) and SystImmune announced that their drug izalontamab brengitecan (iza-bren) has received Breakthrough Therapy Designation (BTD) from the FDA for treating advanced EGFR-mutated non-small cell lung cancer (NSCLC) in patients who progressed after EGFR TKI and platinum-based chemotherapy.
Iza-bren is a first-in-class bispecific antibody-drug conjugate (ADC) targeting both EGFR and HER3 receptors. The BTD was based on promising efficacy and safety data from three ongoing clinical trials: BL-B01D1-101, BL-B01D1-203 (in China), and the global BL-B01D1-LUNG-101 study.
This development addresses a significant unmet need, as NSCLC represents 80% of lung cancer cases, with 10-15% of Western and up to 50% of Asian patients having EGFR mutations. Current treatments typically show resistance after 18 months, highlighting the need for more effective therapies.
Bristol Myers Squibb (NYSE: BMY) e SystImmune hanno comunicato che il loro farmaco izalontamab brengitecan (iza-bren) ha ottenuto la Breakthrough Therapy Designation (BTD) dalla FDA per il trattamento del carcinoma polmonare non a piccole cellule (NSCLC) avanzato con mutazione EGFR in pazienti progrediti dopo EGFR TKI e chemioterapia a base di platino.
Iza-bren 猫 un anticorpo coniugato bispecifico di prima classe (ADC) che mira contemporaneamente ai recettori EGFR e HER3. La BTD si basa su dati di efficacia e sicurezza promettenti provenienti da tre studi clinici in corso: BL-B01D1-101, BL-B01D1-203 (in Cina) e lo studio globale BL-B01D1-LUNG-101.
Questo progresso risponde a un importante bisogno insoddisfatto, dato che il NSCLC rappresenta l'80% dei casi di cancro al polmone, con il 10-15% dei pazienti nelle popolazioni occidentali e fino al 50% in quelle asiatiche portatori di mutazioni EGFR. I trattamenti attuali spesso mostrano resistenza dopo circa 18 mesi, sottolineando la necessit脿 di terapie pi霉 efficaci.
Bristol Myers Squibb (NYSE: BMY) y SystImmune anunciaron que su f谩rmaco izalontamab brengitecan (iza-bren) recibi贸 la Breakthrough Therapy Designation (BTD) de la FDA para el tratamiento del c谩ncer de pulm贸n no microc铆tico (NSCLC) avanzado con mutaci贸n EGFR en pacientes que progresaron tras inhibidores de EGFR (EGFR TKI) y quimioterapia con platino.
Iza-bren es un anticuerpo conjugado con f谩rmaco bispec铆fico de primera clase (ADC) que apunta a los receptores EGFR y HER3. La designaci贸n BTD se fundamenta en datos prometedores de eficacia y seguridad procedentes de tres ensayos cl铆nicos en curso: BL-B01D1-101, BL-B01D1-203 (en China) y el estudio global BL-B01D1-LUNG-101.
Este avance aborda una necesidad cl铆nica importante, ya que el NSCLC representa el 80% de los casos de c谩ncer de pulm贸n, con un 10-15% de pacientes en occidente y hasta un 50% en Asia portadores de mutaciones EGFR. Los tratamientos actuales suelen mostrar resistencia tras unos 18 meses, lo que evidencia la urgencia de opciones terap茅uticas m谩s efectivas.
Bristol Myers Squibb (NYSE: BMY)鞕� SystImmune電� 攴鸽摛鞚� 鞎诫 izalontamab brengitecan (iza-bren)鞚� FDA搿滊秬韯� EGFR 氤�鞚� 牍勳唽靹疙彫韽愳晹(NSCLC) 歆勴枆 頇橃瀽(鞚挫爠 EGFR TKI 氚� 氚标笀 旮半皹 頇旐暀鞖旊矔 頉�)鞐� 雽�頃� 旃橂搿� Breakthrough Therapy Designation(BTD)鞚� 須嶋摑頄堧嫟瓿� 氚濏様雼�.
Iza-bren鞚� EGFR瓿� HER3 靾橃毄觳措ゼ 霃欖嫓鞐� 響滌爜頃橂姅 韻检姢韸胳澑韥措灅鞀� 鞏戧皜靹� 頃泊-鞎诫 鞝戫暕觳�(ADC)雼�. 鞚措矆 BTD電� BL-B01D1-101, BL-B01D1-203(欷戧淡), 鞝勳劯瓿� BL-B01D1-LUNG-101 霌� 3瓯挫潣 歆勴枆 欷戩澑 鞛勳儊鞁滍棙鞐愳劀 鞏混潃 鞙犽頃� 須姤 氚� 鞎堨爠靹� 雿办澊韯半ゼ 攴缄卑搿� 頃滊嫟.
鞚� 臧滊皽鞚� 欷戩殧頃� 氙胳订臁� 靾橃殧毳� 頃搓舶頃滊嫟. NSCLC電� 韽愳晹 靷鞚� 80%毳� 彀頃橂┌, 靹滉惮鞐愳劀電� 10鈥�15%, 鞎勳嫓鞎勳棎靹滊姅 斓滊寑 50%鞚� 頇橃瀽臧� EGFR 氤�鞚措ゼ 氤挫澑雼�. 順勴枆 旃橂氩曥潃 氤错喌 鞎� 18臧滌洈 頉� 鞝�頃劚鞚� 氤挫澊氙�搿� 雿� 須臣鞝侅澑 旃橂氩曥澊 頃勳殧頃橂嫟.
Bristol Myers Squibb (NYSE: BMY) et SystImmune ont annonc茅 que leur m茅dicament izalontamab brengitecan (iza-bren) a obtenu la Breakthrough Therapy Designation (BTD) de la FDA pour le traitement du cancer du poumon non 脿 petites cellules (NSCLC) avanc茅 脿 mutation EGFR chez des patients ayant progress茅 apr猫s un TKI EGFR et une chimioth茅rapie 脿 base de platine.
Iza鈥慴ren est un conjugu茅 anticorps鈥憁茅dicament bisp茅cifique de premi猫re classe (ADC) ciblant 脿 la fois les r茅cepteurs EGFR et HER3. La BTD repose sur des donn茅es d鈥檈fficacit茅 et de s茅curit茅 encourageantes issues de trois essais cliniques en cours : BL-B01D1-101, BL-B01D1-203 (en Chine) et l鈥櫭﹖ude globale BL-B01D1-LUNG-101.
Cette avanc茅e r茅pond 脿 un besoin clinique majeur, car le NSCLC repr茅sente 80 % des cas de cancer du poumon, avec 10鈥�15 % des patients en Occident et jusqu鈥櫭� 50 % en Asie porteurs de mutations EGFR. Les traitements actuels d茅veloppent g茅n茅ralement une r茅sistance apr猫s environ 18 mois, soulignant la n茅cessit茅 de th茅rapies plus efficaces.
Bristol Myers Squibb (NYSE: BMY) und SystImmune gaben bekannt, dass ihr Wirkstoff izalontamab brengitecan (iza-bren) von der FDA die Breakthrough Therapy Designation (BTD) f眉r die Behandlung des fortgeschrittenen EGFR鈥憁utierten nicht鈥慿leinzelligen Lungenkarzinoms (NSCLC) bei Patienten erhalten hat, die nach EGFR鈥慣KI und platinbasierter Chemotherapie progredient sind.
Iza鈥慴ren ist ein erstklassiger bispezifischer Antik枚rper鈥慦irkstoffkonjugat (ADC), das sowohl EGFR- als auch HER3鈥慠ezeptoren adressiert. Die BTD st眉tzt sich auf vielversprechende Wirksamkeits鈥� und Sicherheitsdaten aus drei laufenden klinischen Studien: BL-B01D1-101, BL-B01D1-203 (in China) und der globalen BL-B01D1-LUNG-101-Studie.
Dieser Fortschritt deckt einen erheblichen ungedeckten Bedarf, denn NSCLC macht 80 % der Lungenkrebsf盲lle aus, wobei 10鈥�15 % der westlichen und bis zu 50 % der asiatischen Patienten EGFR鈥慚utationen aufweisen. Aktuelle Therapien zeigen in der Regel nach etwa 18 Monaten Resistenzen, was die Notwendigkeit wirksamerer Behandlungsoptionen unterstreicht.
- First Breakthrough Therapy Designation received for iza-bren, potentially expediting development and review
- Addresses large market opportunity with NSCLC representing 80% of lung cancer cases
- Demonstrates promising efficacy with manageable safety profile in clinical trials
- Novel dual-targeting mechanism potentially offering improved treatment option
- Drug still in clinical trial phase with no guaranteed approval
- Will face competition from existing EGFR TKIs and chemotherapy treatments
- Limited to specific patient population with EGFR mutations
Insights
BTD for iza-bren signals promising efficacy in treatment-resistant lung cancer, potentially accelerating a first-in-class therapy to market.
The FDA's Breakthrough Therapy Designation (BTD) for izalontamab brengitecan represents a significant regulatory milestone that could accelerate this novel bispecific antibody-drug conjugate to market. The designation was based on compelling data from three clinical trials showing efficacy in patients who progressed after both EGFR TKIs and platinum chemotherapy鈥攁 population with limited effective treatment options.
What makes iza-bren particularly notable is its dual-targeting mechanism against both EGFR and HER3 receptors coupled with a topoisomerase 1 inhibitor payload. This approach addresses a critical challenge in NSCLC treatment: while first-line EGFR TKIs like osimertinib show initial efficacy, resistance typically develops after approximately 18 months, leaving patients with few effective options.
The unmet need here is substantial鈥擡GFR mutations occur in 10-15% of Western patients and up to 50% of Asian patients with NSCLC. Current post-TKI options offer limited efficacy with significant toxicity profiles. If approved, iza-bren would become the first bispecific ADC targeting these specific pathways in lung cancer.
The BTD will provide enhanced FDA interaction, potentially expedited review, and rolling submission opportunities. For Bristol Myers Squibb, this represents a valuable addition to their oncology portfolio, particularly in precision medicine for genetically-defined cancers. The collaboration with SystImmune demonstrates BMY's strategic commitment to expanding its pipeline through external innovation in targeted oncology therapeutics.
- First Breakthrough Therapy Designation in the
U.S. for聽SystImmune and Bristol Myers Squibb's Izalontamab brengitecan (Iza-bren) based on data from the BL-B01D1-101 (CN), BL-B01D1-203 (CN), and BL-B01D1-LUNG-101 (U.S. ,/EU) studies
Iza-bren is a potential first-in-class bispecific antibody-drug conjugate (ADC) which targets both epidermal growth factor receptor and human epidermal growth factor receptor 3 (EGFRxHER3) with a topoisomerase 1 inhibitor payload. Iza-bren is being developed by Biokin in
The granting of聽BTD underscores the strength of these data and highlights the potential of iza-bren to address the significant clinical unmet need patients face after EGFR TKI and platinum-based chemotherapy treatment. While EGFR TKIs have shown clinical efficacy in the frontline setting, most patients eventually see their cancer progress after about 18 months. Subsequent treatment options often contain platinum-based chemotherapy, which are of limited efficacy and come with significant聽toxicities. Breakthrough Therapy Designation from the US FDA is intended to expedite the development and review of drugs that may demonstrate significant benefit over current standards of care.
The FDA's decision was based on efficacy and safety data from three ongoing clinical trials: BL-B01D1-101 and BL-B01D1-203, conducted in
"The FDA's granting of Breakthrough Therapy Designation underscores the potential of聽iza-bren to meaningfully improve clinical outcomes for patients with previously treated epidermal growth factor receptor mutation NSCLC," said Dr. Jonathan Cheng, Chief Medical Officer of SystImmune. "The data we have generated to date suggest that聽iza-bren could address a critical unmet need in patient care, and we look forward to working closely with the FDA to conduct the relevant clinical studies and seek regulatory approval."
About聽EGFRmt NSCLC
Non-small cell lung cancer (NSCLC) accounts for approximately
础产辞耻迟听颈锄补-产谤别苍
SystImmune, in collaboration with BMS outside of
About SystImmune
SystImmune is a clinical-stage biopharmaceutical company located in
About Bristol聽Myers Squibb
Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at or follow us on , , , and .
SystImmune Forward-Looking Statements
Any research and development information provided by SystImmune is intended for general information purposes only. Such information is not intended to provide complete medical information. We do not offer patient-specific treatment advice and if you have medical conditions, please see your medical doctor or healthcare provider.
This press release may contain forward-looking statements with the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, and the Private Securities Litigation Reform Act of 1995, which reflects the expectations regarding the company's goals, strategies, results of operations, performance, business prospects, and opportunities, including but not limited to the ability to gain Investigational New Drug status for the resulting new product and the ability to develop a successful formulation. Terms such as "anticipates," "believes," "expects," "estimates," "could," "intends," "may," "plans," "potential," "projects," "will," "would" and other similar expressions, or the negative of these terms, are generally indicative of forward-looking statements.
While SystImmune, Inc. believes that expectations expressed in the forward-looking statements are based on the company's reasonable assumptions and beliefs in light of the information available to the company at the time such statements are made, it cannot give assurance that such forward-looking statements will prove to have been correct. Such forward-looking statements are not fact and are subject to uncertainties and other factors that could cause actual results to differ materially from such statements. We undertake no obligation to update any forward-looking statements contained in this press release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.
For additional information about the company, please visit聽.
Bristol聽Myers Squibb Cautionary Statement Regarding Forward-Looking Statements
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the research, development and commercialization of pharmaceutical products described herein and the collaboration with SystImmune. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. Such forward-looking statements are based on current expectations and projections about our future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond our control and could cause our future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. These risks, assumptions, uncertainties and other factors include, among others, that the expected benefits of, and opportunities related to, the collaboration with SystImmune may not be realized by Bristol Myers Squibb or may take longer to realize than anticipated, that the therapeutic potential of Iza-bren (BL-B01D1) may change, that Bristol Myers Squibb may fail to discover and develop any commercially successful product candidates through the collaboration with SystImmune, that such product candidates may not receive regulatory approval for the indications described in this release and, if approved, whether such product candidates will be commercially successful.
No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect Bristol Myers Squibb's business and market, particularly those identified in the cautionary statement and risk factors discussion in Bristol Myers Squibb's Annual Report on Form 10-K for the year ended December 31, 2024, as updated by our subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the Securities and Exchange Commission. The forward-looking statements included in this document are made only as of the date of this document and except as otherwise required by applicable law, Bristol Myers Squibb undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise.
View original content to download multimedia:
SOURCE SystImmune, Inc.
FAQ
What is the significance of BTD status for Bristol Myers Squibb's (BMY) iza-bren?
How does iza-bren work differently from existing NSCLC treatments?
What is the market potential for BMY's iza-bren in NSCLC treatment?
Which clinical trials supported the BTD for Bristol Myers Squibb's iza-bren?
What patient population will BMY's iza-bren target?
