- First regimen to be approved in India
to demonstrate superiority to platinum-containing chemotherapy, the current
standard of care for adult patients with unresectable or metastatic urothelial
cancer for nearly 40 years -
- Central Drugs Standard Control
Organization approval was based on the global Phase 3 EV-302 trial (also
known as KEYNOTE-A39) where the combination treatment nearly doubled median
overall survival and significantly extended progression free survival outcomes1
-
Mumbai, India, 21st May 2026 : Astellas Pharma India today announced
that PADCEVTM (enfortumab vedotin) in combination with pembrolizumab
is now approved for the first-line treatment of adult patients with
unresectable or metastatic urothelial cancer who are eligible for platinum-containing
chemotherapy in India. This is the first approved combination therapy in India
to offer an alternative to platinum-containing chemotherapy, the current
standard of care for first-line treatment of advanced urothelial cancer.
The approval by Central Drugs
Standard Control Organization was supported by results from the Phase 3
EV-302 clinical trial which explored the efficacy and safety of enfortumab
vedotin in combination with pembrolizumab in patients with previously untreated
locally advanced or metastatic urothelial cancer (la/mUC).1 The
treatment combination resulted in a median overall survival of 31.5 months (95%
CI: 25.4-NR) compared to 16.1 months (95% CI: 13.9-18.3) with
platinum-containing chemotherapy, with a hazard ratio of 0.47 indicating a 53%
reduction in risk of death (95% Confidence Interval [CI]: 0.38-0.58;
P<0.00001).1 Furthermore, the treatment combination resulted in a
median progression-free survival of 12.5 months (95% CI: 10.4-16.6) compared to
6.3 months (95% CI: 6.2-6.5) with chemotherapy, with a hazard ratio of 0.45
indicating a 55% reduction in the risk of cancer progression or death (95% CI:
(0.38-0.54); P<0.00001).1
The safety results in EV-302 are
consistent with those previously reported for this combination in EV-103 in
cisplatin-ineligible patients with la/mUC. The most common (≥3%) Grade 3 or
higher adverse events (AEs) related to treatment with enfortumab vedotin in
combination with pembrolizumab were maculo-papular rash, hyperglycemia,
neutropenia, peripheral sensory neuropathy, diarrhea, and anemia. No new safety
signals were identified.1
Enfortumab vedotin in combination with
pembrolizumab has also been approved in the US, Europe, Canada, Australia and a
number of countries in Asia.
About EV-302
The EV-302 trial is an open-label,
randomized, controlled Phase 3 study, evaluating enfortumab vedotin in
combination with pembrolizumab versus platinum-containing chemotherapy in
patients with previously untreated la/mUC. The study enrolled 886 patients with
previously untreated la/mUC who were eligible for cisplatin- or
carboplatin-containing chemotherapy regardless of PD-L1 status. Patients were
randomized to receive either enfortumab vedotin in combination with
pembrolizumab or platinum-containing chemotherapy. The dual primary endpoints
of this trial are OS and PFS per RECIST v1.1 by blinded independent central
review (BICR). Select secondary endpoints include ORR per RECIST v1.1 by BICR,
DOR per RECIST v1.1 by BICR, and safety.1
The EV-302 trial is part of an extensive
clinical program evaluating this combination in multiple stages of urothelial
cancer and other solid tumors. Findings from EV-302 were presented at the 2023 European Society for
Medical Oncology (ESMO) Congress and published in the New England Journal of
Medicine.1
About PADCEVTM (enfortumab
vedotin [genetical recombination])
PADCEV (enfortumab vedotin [genetical
recombination]) is a first-in-class antibody-drug conjugate (ADC) that is
directed against Nectin-4, a protein located on the surface of cells and highly
expressed in bladder cancer., Non-clinical data suggest the
anticancer activity of enfortumab vedotin is due to its binding to
Nectin-4-expressing cells, followed by the internalization and release of the
anti-tumor agent monomethyl auristatin E (MMAE) into the cell, which result in the
cell not reproducing (cell cycle arrest) and in programmed cell death
(apoptosis).10
PADCEV is indicated in combination with
pembrolizumab, for the first-line treatment of adult patients with unresectable
or metastatic urothelial cancer who are eligible for platinum-containing
chemotherapy.
PADCEV as monotherapy is indicated for
the treatment of adult patients with locally advanced or metastatic urothelial
cancer who have previously received a platinum-containing chemotherapy and a
programmed death receptor 1 or programmed death ligand 1 inhibitor.
Important Safety Information
For important Safety Information for
PADCEV, submit your inquiry through our webform - https://www.astellas.com/in/medicines-information-submission
About Astellas
Astellas is a global life sciences
company committed to turning innovative science into VALUE for patients. We
provide transformative therapies in disease areas that include oncology,
ophthalmology, urology, immunology and women's health. Through our research and
development programs, we are pioneering new healthcare solutions for diseases
with high unmet medical need. Learn more at www.astellas.com.
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performance of Astellas. These statements are based on management's current
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and involve known and unknown risks and uncertainties. A number of factors
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Contacts for inquiries or additional information:
Astellas Pharma India Private Limited
301, 3rd Floor, C & B Square, 127, Andheri Kurla Road, Andheri (East),
Mumbai 400069 India, Customer care no. +91-22-61557600
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1.Powles
T, et al. Enfortumab Vedotin and Pembrolizumab in Untreated Advanced Urothelial
Cancer. N Engl J Med. 2024;390:875-888.
2.
PADCEV India Approval Letter.
3.
Challita-Eid PM, et al. Enfortumab vedotin antibody-drug conjugate targeting
nectin-4 is a highly potent therapeutic agent in multiple preclinical cancer
models. Cancer Res. 2016;76(10):3003-13.