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TIVDAK® (tisotumab vedotin) Approved by Japan Ministry of Health, Labour and Welfare for the Treatment of Advanced or Recurrent Cervical Cancer that has Progressed on or after Chemotherapy

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TIVDAK® (tisotumab vedotin) has received approval from Japan's Ministry of Health, Labour and Welfare for treating advanced or recurrent cervical cancer that has progressed after chemotherapy. This marks a significant milestone as TIVDAK becomes the first and only antibody-drug conjugate (ADC) approved for cervical cancer patients in Japan.

The approval is supported by the global Phase 3 innovaTV 301 trial results, which demonstrated superior overall survival compared to chemotherapy. The study showed a 30% reduction in risk of death, with median overall survival of 11.5 months for TIVDAK versus 9.5 months for chemotherapy. The trial included 502 patients, with 101 being Japanese.

Common adverse reactions, observed in 87.6% of 250 treated patients, included conjunctivitis (30.4%), nausea (29.2%), peripheral sensory neuropathy (26.8%), alopecia (24.4%), and epistaxis (22.8%).

TIVDAK® (tisotumab vedotin) ha ricevuto l'approvazione dal Ministero della Salute, del Lavoro e del Welfare del Giappone per il trattamento del cancro cervicale avanzato o ricorrente che è progredito dopo la chemioterapia. Questo rappresenta una pietra miliare significativa poiché TIVDAK diventa il primo e unico coniugato anticorpale-farmaco (ADC) approvato per i pazienti con cancro cervicale in Giappone.

L'approvazione è supportata dai risultati del trial globale di Fase 3 innovaTV 301, che ha dimostrato una superiore sopravvivenza globale rispetto alla chemioterapia. Lo studio ha mostrato una riduzione del 30% del rischio di morte, con una sopravvivenza mediana di 11,5 mesi per TIVDAK rispetto a 9,5 mesi per la chemioterapia. Il trial ha incluso 502 pazienti, di cui 101 giapponesi.

Le reazioni avverse comuni, osservate nel 87,6% dei 250 pazienti trattati, includevano congiuntivite (30,4%), nausea (29,2%), neuropatia sensoriale periferica (26,8%), alopecia (24,4%) ed epistassi (22,8%).

TIVDAK® (tisotumab vedotin) ha recibido la aprobación del Ministerio de Salud, Trabajo y Bienestar de Japón para el tratamiento del cáncer cervical avanzado o recurrente que ha progresado tras la quimioterapia. Esto marca un hito significativo, ya que TIVDAK se convierte en el primer y único conjugado anticuerpo-fármaco (ADC) aprobado para pacientes con cáncer cervical en Japón.

La aprobación está respaldada por los resultados del ensayo global de Fase 3 innovaTV 301, que demostró una superior supervivencia global en comparación con la quimioterapia. El estudio mostró una reducción del 30% en el riesgo de muerte, con una supervivencia media de 11,5 meses para TIVDAK frente a 9,5 meses para la quimioterapia. El ensayo incluyó a 502 pacientes, de los cuales 101 eran japoneses.

Las reacciones adversas comunes, observadas en el 87,6% de los 250 pacientes tratados, incluyeron conjuntivitis (30,4%), náuseas (29,2%), neuropatía sensorial periférica (26,8%), alopecia (24,4%) y epistaxis (22,8%).

TIVDAK® (티소투맙 베도틴)은 일본 보건복지부의 승인을 받아 화학요법 후 진행된 고급 또는 재발성 자궁경부암 치료에 사용됩니다. 이는 TIVDAK이 일본에서 자궁경부암 환자를 위한 최초이자 유일한 항체-약물 접합체(ADC)로 승인받았다는 중요한 이정표입니다.

이 승인은 화학요법에 비해 우수한 전체 생존율을 보여준 글로벌 3상 임상시험인 innovaTV 301의 결과에 의해 뒷받침됩니다. 연구에서는 TIVDAK이 11.5개월의 중앙 전체 생존율을 기록한 반면, 화학요법은 9.5개월로 사망 위험을 30% 감소시키는 것으로 나타났습니다. 이 시험에는 502명의 환자가 포함되었으며, 그중 101명이 일본인이었습니다.

250명의 치료 환자 중 87.6%에서 관찰된 일반적인 부작용으로는 결막염(30.4%), 메스꺼움(29.2%), 말초 감각 신경병증(26.8%), 탈모(24.4%) 및 비출혈(22.8%)이 있었습니다.

TIVDAK® (tisotumab vedotin) a reçu l'approbation du ministère japonais de la Santé, du Travail et du Bien-être pour le traitement du cancer du col de l'utérus avancé ou récurrent ayant progressé après une chimiothérapie. Cela marque une étape importante, TIVDAK devenant le premier et unique conjugé anticorps-médicament (ADC) approuvé pour les patients atteints de cancer du col de l'utérus au Japon.

Cette approbation est soutenue par les résultats de l'essai mondial de phase 3 innovaTV 301, qui a démontré une survie globale supérieure par rapport à la chimiothérapie. L'étude a montré une réduction de 30 % du risque de décès, avec une survie médiane de 11,5 mois pour TIVDAK contre 9,5 mois pour la chimiothérapie. L'essai a inclus 502 patients, dont 101 étaient japonais.

Les réactions indésirables courantes, observées chez 87,6 % des 250 patients traités, comprenaient conjonctivite (30,4 %), nausées (29,2 %), neuropathie sensorielle périphérique (26,8 %), alopécie (24,4 %) et épistaxis (22,8 %).

TIVDAK® (tisotumab vedotin) hat die Genehmigung des japanischen Ministeriums für Gesundheit, Arbeit und Wohlfahrt zur Behandlung von fortgeschrittenem oder wiederkehrendem Gebärmutterhalskrebs erhalten, der nach einer Chemotherapie fortgeschritten ist. Dies stellt einen bedeutenden Meilenstein dar, da TIVDAK das erste und einzige Antikörper-Wirkstoff-Konjugat (ADC) ist, das für Gebärmutterhalskrebspatienten in Japan zugelassen wurde.

Die Genehmigung wird durch die Ergebnisse der globalen Phase-3-Studie innovaTV 301 unterstützt, die eine überlegene Gesamtüberlebensrate im Vergleich zur Chemotherapie zeigte. Die Studie ergab eine 30%ige Reduktion des Sterberisikos, mit einer medianen Gesamtüberlebenszeit von 11,5 Monaten für TIVDAK im Vergleich zu 9,5 Monaten für die Chemotherapie. Die Studie umfasste 502 Patienten, darunter 101 Japaner.

Häufige unerwünschte Reaktionen, die bei 87,6% der 250 behandelten Patienten beobachtet wurden, umfassten Konjunktivitis (30,4%), Übelkeit (29,2%), periphere sensorische Neuropathie (26,8%), Alopezie (24,4%) und Nasenbluten (22,8%).

Positive
  • First and only ADC approved for cervical cancer in Japan, expanding market presence
  • Demonstrated 30% reduction in death risk in Phase 3 trial
  • Met all primary and secondary endpoints in clinical trial
  • Addresses growing medical need in Japan with increasing cervical cancer rates
Negative
  • High rate (87.6%) of adverse reactions in treated patients
  • survival benefit of 2 months compared to chemotherapy (11.5 vs 9.5 months)

Insights

The approval of TIVDAK in Japan represents a significant commercial milestone for Genmab. As the first and only antibody-drug conjugate approved for cervical cancer in this market, Genmab has secured an important competitive advantage. The timing is particularly strategic given the concerning trend of increasing cervical cancer rates in Japan, especially among women under 50.

The Phase 3 innovaTV 301 trial data supporting this approval demonstrated compelling efficacy with a 30% reduction in risk of death compared to chemotherapy. This translates to a median overall survival of 11.5 months versus 9.5 months for chemotherapy - a meaningful improvement in a difficult-to-treat patient population with options.

This approval strengthens Genmab's global commercialization strategy for TIVDAK, expanding beyond the US market into a significant Asian healthcare economy. The product's novel mechanism of action addresses the critical unmet need for second-line treatments with improved survival benefits. From a competitive standpoint, being first-to-market with an ADC therapy for this indication provides Genmab with a unique market position in Japan's oncology landscape.

While the safety profile shows common adverse reactions including conjunctivitis (30.4%) and nausea (29.2%), these appear manageable and consistent with previous studies, supporting the positive benefit-risk profile that enabled regulatory approval.

The approval of TIVDAK in Japan addresses a critical treatment gap for advanced cervical cancer patients who have progressed after chemotherapy. The clinical significance of this approval cannot be overstated - the 30% reduction in mortality risk (HR: 0.70) demonstrated in the innovaTV 301 trial represents a meaningful survival advantage in a patient population with historically poor outcomes.

The 2-month improvement in median overall survival (11.5 vs. 9.5 months) may appear modest, but in the context of recurrent cervical cancer, where progress has been incremental, this benefit is clinically meaningful. Importantly, the trial also met its secondary endpoints of progression-free survival and objective response rate, providing a comprehensive efficacy profile.

The antibody-drug conjugate technology employed in TIVDAK represents an important therapeutic advance by specifically targeting tissue factor, which is highly expressed in cervical cancer cells. This targeted approach potentially offers improved efficacy while limiting systemic toxicity compared to traditional chemotherapy.

The safety profile, while showing expected ADC-related toxicities like conjunctivitis, peripheral neuropathy and epistaxis, appears manageable with appropriate monitoring. The benefit-risk assessment clearly favored approval, particularly given the treatment landscape for these patients. Japanese physicians now have access to a novel mechanistic approach that can meaningfully extend survival for women facing this challenging diagnosis.

  • TIVDAK® is the first and only antibody-drug conjugate (ADC) approved for patients with advanced or recurrent cervical cancer in Japan
  • Approval is based on results from the global Phase 3 innovaTV 301 trial, in which TIVDAK demonstrated superior overall survival compared to chemotherapy
  • Rising cervical cancer incidence and mortality rates in Japan signify need for new treatment options

COPENHAGEN, Denmark--(BUSINESS WIRE)-- Genmab A/S (Nasdaq: GMAB) today announced that the Japan Ministry of Health, Labour and Welfare has approved TIVDAK® (tisotumab vedotin) for the treatment of advanced or recurrent cervical cancer that has progressed on or after cancer chemotherapy. TIVDAK is the first and only ADC to be approved for people living with cervical cancer in Japan.

In recent years, cervical cancer incidence and mortality rates have increased in Japan, particularly among women under age 50.i,ii,iii Moreover, patients with recurrent or metastatic cervical cancer whose disease has progressed after first-line therapy have limited treatment options.

“Patients with advanced or recurrent cervical cancer, in general, have a poor prognosis. The advent of new treatment options, especially for second-line or later treatment, is much needed,” said Aikou Okamoto, M.D., Ph.D., Chief Professor, Department of Obstetrics and Gynecology at The Jikei University School of Medicine. “Cervical cancer treatment has advanced in recent years, but it is very meaningful that the approval of tisotumab vedotin as an ADC has increased the number of treatment options with a new mechanism of action that is expected to prolong overall survival. This is good news for patients and healthcare professionals.”

The approval is based on data from the randomized, open-label, global Phase 3 innovaTV 301 clinical trial that evaluated the efficacy and safety of TIVDAK compared to chemotherapy in patients with advanced or recurrent cervical cancer who were previously treated with chemotherapy. The trial included 502 patients, 101 of which were Japanese. The trial met its primary endpoint of overall survival (OS), demonstrating a 30% reduction in risk of death (HR: 0.70 [95% CI: 0.54-0.89], two-sided p=0.0038) compared to chemotherapy. Median OS was 11.5 months [95% CI: 9.8-14.9] among patients treated with TIVDAK compared to 9.5 months [95% CI: 7.9-10.7] for patients who received chemotherapy. Secondary endpoints of progression-free survival (PFS) and confirmed objective response rate (ORR) were also met.

Adverse drug reactions occurred in 219 (87.6%) of 250 patients (including 50 Japanese patients) treated with TIVDAK. The most common (≥20%) adverse reactions included conjunctivitis (n=76; 30.4%), nausea (n=73; 29.2%), peripheral sensory neuropathy (n=67; 26.8%), alopecia (n=61; 24.4%), and epistaxis (n=57; 22.8%), at the data cutoff date of July 24, 2023.

“As a company, we understand the urgent need for patients with advanced cervical cancer whose disease has progressed,” said Judith Klimovsky, M.D., Executive Vice President and Chief Development Officer of Genmab. “This approval marks an important step forward in transforming the treatment paradigm in Japan, ultimately bringing new hope and possibility to patients and their loved ones.”

About the innovaTV 301 Trial

The innovaTV 301 trial (NCT04697628) is a global, 1:1 randomized, open-label Phase 3 trial evaluating tisotumab vedotin versus investigator’s choice of single agent chemotherapy (topotecan, vinorelbine, gemcitabine, irinotecan or pemetrexed) in 502 patients with recurrent or metastatic cervical cancer who received one or two prior systemic regimens in the recurrent or metastatic setting.

Patients with recurrent or metastatic cervical cancer with squamous cell, adenocarcinoma or adenosquamous histology, and disease progression during or after treatment with chemotherapy doublet +/- bevacizumab and an anti-PD-(L)1 agent (if eligible) are included. The primary endpoint was overall survival. The main secondary outcomes were progression-free survival and objective response rate.

The study was conducted by Seagen, which was acquired by Pfizer in December 2023, in collaboration with Genmab, European Network of Gynaecological Oncological Trial Groups (ENGOT, study number ENGOT cx-12) and the Gynecologic Oncology Group (GOG) Foundation (study number GOG 3057), as well as other global gynecological oncology cooperative groups. For more information about the Phase 3 innovaTV 301 clinical trial and other clinical trials with tisotumab vedotin, please visit www.clinicaltrials.gov.

About Tisotumab Vedotin

Tisotumab vedotin (approved under the brand name TIVDAK® in the U.S. and Japan) is an antibody-drug conjugate (ADC) composed of Genmab’s human monoclonal antibody directed to tissue factor (TF) and Pfizer’s ADC technology that utilizes a protease-cleavable linker that covalently attaches the microtubule-disrupting agent monomethyl auristatin E (MMAE) to the antibody. Nonclinical data suggest that the anticancer activity of tisotumab vedotin is due to the binding of the ADC to TF-expressing cancer cells, followed by internalization of the ADC-TF complex and release of MMAE via proteolytic cleavage. MMAE disrupts the microtubule network of actively dividing cells, leading to cell cycle arrest and apoptotic cell death. In vitro, tisotumab vedotin also mediates antibody-dependent cellular phagocytosis and antibody-dependent cellular cytotoxicity.

About the Pfizer and Genmab Collaboration

Tisotumab vedotin is co-developed and co-commercialized globally by Genmab and Pfizer, under an agreement in which the companies share costs and profits.

With respect to the commercialization of tisotumab vedotin in previously treated recurrent or metastatic cervical cancer, Genmab leads commercialization in Japan and all other regions globally, outside the United States and China. In these regions, Pfizer partners with Genmab and Zai Lab, respectively, on commercialization.

TIVDAK® (tisotumab vedotin-tftv) U.S. Indication and Important Safety Information

Indication

TIVDAK is a tissue factor-directed antibody and microtubule inhibitor conjugate indicated for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.

Important Safety Information

BOXED WARNING: OCULAR TOXICITY

TIVDAK can cause severe ocular toxicities resulting in changes in vision, including severe vision loss, and corneal ulceration. Conduct an ophthalmic exam, including an assessment of ocular symptoms, visual acuity, and slit lamp exam of the anterior segment of the eye prior to initiation of TIVDAK, prior to every cycle for the first nine cycles, and as clinically indicated. Adhere to the required premedication and eye care before, during, and after infusion. Withhold TIVDAK until improvement and resume, reduce the dose, or permanently discontinue, based on severity.

Warnings and Precautions

Ocular adverse reactions: TIVDAK can cause severe ocular adverse reactions, including conjunctivitis, keratopathy (keratitis, punctate keratitis, and ulcerative keratitis), and dry eye (increased lacrimation, eye pain, eye discharge, pruritus, irritation, and foreign body sensation), that may lead to changes in vision and/or corneal ulceration.

Ocular adverse reactions occurred in 55% of patients with cervical cancer treated with TIVDAK across clinical trials. The most common were conjunctivitis (32%), dry eye (24%), keratopathy (17%), and blepharitis (5%). Grade 3 ocular adverse reactions occurred in 3.3% of patients, including severe ulcerative keratitis in 1.2% of patients. Nine patients (2.1%) experienced ulcerative keratitis (including one with perforation requiring corneal transplantation), six (1.4%) conjunctival ulcer, four (0.9%) corneal erosion, two (0.5%) conjunctival erosion, and two (0.5%) symblepharon.

In innovaTV 301, 8 patients (3.2%) experienced delayed ocular adverse reactions occurring more than 30 days after discontinuation of TIVDAK. These adverse reactions included 3 patients with ulcerative keratitis, and one patient (each) with keratitis, punctate keratitis and corneal erosion, blepharitis and conjunctival hyperemia, conjunctival scar, and conjunctivitis and xerophthalmia.

Refer patients to an eye care provider to conduct an ophthalmic exam prior to initiation of TIVDAK, prior to every cycle for the first nine cycles, and as clinically indicated. The exam should include visual acuity, slit lamp exam of the anterior segment of the eye, and an assessment of normal eye movement and ocular signs or symptoms which include dry or irritated eyes, eye secretions, or blurry vision.

Adhere to the required premedication and eye care before, during, and after infusion to reduce the risk of ocular adverse reactions. Monitor for ocular toxicity and promptly refer patients to an eye care provider for any new or worsening ocular signs and symptoms. Withhold, reduce, or permanently discontinue TIVDAK based on the severity or persistence of the ocular adverse reaction.

Peripheral Neuropathy (PN) occurred in 39% of cervical cancer patients treated with TIVDAK across clinical trials; 6% of patients experienced Grade 3 PN. PN adverse reactions included peripheral sensory neuropathy (23%), PN (5%), paresthesia (3.8%), peripheral sensorimotor neuropathy (3.3%), muscular weakness (2.8%), and peripheral motor neuropathy (2.4%). One patient with another tumor type treated with TIVDAK at the recommended dose developed Guillain-Barre syndrome.

Monitor patients for signs and symptoms of neuropathy such as paresthesia, tingling or a burning sensation, neuropathic pain, muscle weakness, or dysesthesia. For new or worsening PN, withhold, then dose reduce, or permanently discontinue TIVDAK based on the severity of PN.

Hemorrhage occurred in 51% of cervical cancer patients treated with TIVDAK across clinical trials. The most common all grade hemorrhage adverse reaction was epistaxis (33%). Grade 3 hemorrhage occurred in 4% of patients.

Monitor patients for signs and symptoms of hemorrhage. For patients experiencing pulmonary or central nervous system hemorrhage, permanently discontinue TIVDAK. For Grade ≥2 hemorrhage in any other location, withhold until bleeding has resolved, blood hemoglobin is stable, there is no bleeding diathesis that could increase the risk of continuing therapy, and there is no anatomical or pathologic condition that can increase the risk of hemorrhage recurrence. After resolution, either resume treatment or permanently discontinue TIVDAK.

Pneumonitis that is severe, life-threatening, or fatal can occur in patients treated with antibody-drug conjugates containing vedotin, including TIVDAK. Among cervical cancer patients treated with TIVDAK across clinical trials, 4 patients (0.9%) experienced pneumonitis, including 1 patient who had a fatal outcome.

Monitor patients for pulmonary symptoms of pneumonitis. Symptoms may include hypoxia, cough, dyspnea or interstitial infiltrates on radiologic exams. Infectious, neoplastic, and other causes for such symptoms should be excluded through appropriate investigations. Withhold TIVDAK for patients who develop persistent or recurrent Grade 2 pneumonitis and consider dose reduction. Permanently discontinue TIVDAK in all patients with Grade 3 or 4 pneumonitis.

Severe cutaneous adverse reactions (SCAR), including events of fatal or life-threatening Stevens-Johnson syndrome (SJS), can occur in patients treated with TIVDAK. SCAR occurred in 1.6% of cervical cancer patients treated with TIVDAK across clinical trials. Grade ≥3 SCAR occurred in 0.5% of patients, including 1 patient who had a fatal outcome.

Monitor patients for signs or symptoms of SCAR, which include target lesions, worsening skin reactions, blistering or peeling of the skin, painful sores in mouth, nose, throat, or genital area, fever or flu-like symptoms, and swollen lymph nodes. If signs or symptoms of SCAR occur, withhold TIVDAK until the etiology of the reaction has been determined. Early consultation with a specialist is recommended to ensure greater diagnostic accuracy and appropriate management. Permanently discontinue TIVDAK for confirmed Grade 3 or 4 SCAR, including SJS.

Embryo-fetal toxicity: TIVDAK can cause fetal harm when administered to a pregnant woman. Advise patients of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with TIVDAK and for 2 months after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with TIVDAK and for 4 months after the last dose.

Adverse Reactions

Across clinical trials of TIVDAK in 425 patients with r/mCC, the most common (≥25%) adverse reactions, including laboratory abnormalities, were hemoglobin decreased (45%), PN (39%), conjunctival adverse reactions (38%), nausea (37%), fatigue (36%), aspartate aminotransferase increased (33%), epistaxis (33%), alopecia (31%), alanine aminotransferase increased (30%), and hemorrhage (28%).

innovaTV 301 Study: 250 patients with r/mCC with disease progression on or after systemic therapy

Serious adverse reactions occurred in 33% of patients receiving TIVDAK; the most common (≥2%) were urinary tract infection (4.8%), small intestinal obstruction (2.4%), sepsis, abdominal pain, and hemorrhage (each 2%). Fatal adverse reactions occurred in 1.6% of patients who received TIVDAK, including acute kidney injury, pneumonia, sepsis, and SJS (each 0.4%).

Adverse reactions leading to permanent discontinuation occurred in 15% of patients receiving TIVDAK; the most common (≥3%) were PN and ocular adverse reactions (each 6%). Adverse reactions leading to dose interruption occurred in 39% of patients receiving TIVDAK; the most common (≥3%) were ocular adverse reactions (16%) and PN (6%). Adverse reactions leading to dose reduction occurred in 30% of patients receiving TIVDAK; the most common (≥3%) were PN and ocular adverse reactions (each 10%). The ocular adverse reactions included conjunctival disorders (4.8%), keratopathy (4%), and dry eye (0.8%).

innovaTV 204 Study: 101 patients with r/mCC with disease progression on or after chemotherapy

Serious adverse reactions occurred in 43% of patients; the most common (≥3%) were ileus (6%), hemorrhage (5%), pneumonia (4%), PN, sepsis, constipation, and pyrexia (each 3%). Fatal adverse reactions occurred in 4% of patients who received TIVDAK, including septic shock, pneumonitis, sudden death, and multisystem organ failure (each 1%).

Adverse reactions leading to permanent discontinuation occurred in 13% of patients receiving TIVDAK; the most common (≥3%) were PN (5%) and corneal adverse reactions (4%). Adverse reactions leading to dose interruption occurred in 47% of patients; the most common (≥3%) were PN (8%), conjunctival adverse reactions, and hemorrhage (each 4%). Adverse reactions leading to dose reduction occurred in 23% of patients; the most common (≥3%) were conjunctival adverse reactions (9%) and corneal adverse reactions (8%).

Drug Interactions

Strong CYP3A4 inhibitors: Concomitant use with strong CYP3A4 inhibitors may increase unconjugated monomethyl auristatin E (MMAE) exposure, which may increase the risk of TIVDAK adverse reactions. Closely monitor patients for TIVDAK adverse reactions.

Use in Specific Populations

Moderate or severe hepatic impairment: MMAE exposure and adverse reactions are increased. Avoid use.

Lactation: Advise lactating women not to breastfeed during TIVDAK treatment and for at least 3 weeks after the last dose.

Please see full U.S. prescribing information, including BOXED WARNING for TIVDAK here.

About Genmab

Genmab is an international biotechnology company with a core purpose of guiding its unstoppable team to strive toward improving the lives of patients with innovative and differentiated antibody therapeutics. For more than 25 years, its passionate, innovative and collaborative team has invented next-generation antibody technology platforms and leveraged translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. By 2030, Genmab’s vision is to transform the lives of people with cancer and other serious diseases with knock-your-socks-off (KYSO®) antibody medicines.

Established in 1999, Genmab is headquartered in Copenhagen, Denmark, with international presence across North America, Europe and Asia Pacific. For more information, please visit Genmab.com and follow us on LinkedIn and X.

This Media Release contains forward looking statements. The words “believe,” “expect,” “anticipate,” “intend” and “plan” and similar expressions identify forward looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with preclinical and clinical development of products, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products or technologies obsolete, and other factors. For a further discussion of these risks, please refer to the risk management sections in Genmab’s most recent financial reports, which are available on www.genmab.com and the risk factors included in Genmab’s most recent Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission (SEC), which are available at www.sec.gov. Genmab does not undertake any obligation to update or revise forward looking statements in this Media Release nor to confirm such statements to reflect subsequent events or circumstances after the date made or in relation to actual results, unless required by law.

Genmab A/S and/or its subsidiaries own the following trademarks: Genmab®; the Y-shaped Genmab logo®; Genmab in combination with the Y-shaped Genmab logo®; HuMax®; DuoBody®; HexaBody®; DuoHexaBody®, HexElect® and KYSO®.

____________________

i Cancer Statistics Cervix, National Cancer Center, Cancer Information Service, ganjoho.jp/reg_stat/statistics/stat/cancer/17_cervix_uteri.html#anchor1. Accessed 14 Feb. 2025.

ii Trends in Cancer Incidence and Mortality Rates, World Health Organization, gco.iarc.fr/overtime/en. Accessed 14 Feb. 2025.

iii For Correct Understanding of Cervical Cancer and HPV Vaccine, Japan Society of Obstetrics and Gynecology, www.jsog.or.jp/citizen/5765/. Accessed 14 Feb. 2025.

 

Caitlin Craparo, Senior Director, Commercialization Communications

T: +1 609 255 7397; E: cacr@genmab.com

Andrew Carlsen, Vice President, Head of Investor Relations

T: +45 3377 9558; E: acn@genmab.com

Source: Genmab A/S

FAQ

What are the survival benefits of TIVDAK (GMAB) shown in the Phase 3 trial?

TIVDAK demonstrated a 30% reduction in death risk with median overall survival of 11.5 months compared to 9.5 months for chemotherapy.

What are the most common side effects of TIVDAK reported in the Japanese approval?

The most common side effects include conjunctivitis (30.4%), nausea (29.2%), peripheral sensory neuropathy (26.8%), alopecia (24.4%), and epistaxis (22.8%).

How many Japanese patients were included in the TIVDAK Phase 3 trial?

The Phase 3 innovaTV 301 trial included 101 Japanese patients out of 502 total participants.

What makes TIVDAK's approval significant in the Japanese market?

TIVDAK is the first and only antibody-drug conjugate (ADC) approved for cervical cancer in Japan, where incidence and mortality rates are increasing, especially among women under 50.
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