REG - GSK PLC - GSK Lung Cancer ADC Gets Japan Orphan Drug Status

GSKAnnouncement

Mon 07:00

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RNS Number : 5819X  GSK PLC  23 March 2026

Issued: 23 March 2026, London UK

 

GSK's B7-H3-targeted antibody-drug conjugate, risvutatug rezetecan, granted
Orphan Drug Designation for small-cell lung cancer in Japan

 

·   Designation supported by early clinical data showing durable responses
in certain types of small-cell lung cancer (SCLC)

·   Extensive-stage SCLC is associated with high rates of relapse, few
treatment options and poor prognosis

·   Sixth global regulatory designation for risvutatug rezetecan supporting
GSK's investigational ADC with transformational potential in solid tumours

 

GSK plc (LSE/NYSE: GSK) today announced that risvutatug rezetecan (or Ris-Rez,
for short), a B7-H3-targeted antibody-drug conjugate (ADC), has received
Orphan Drug Designation (ODD) from Japan's Ministry of Health, Labour and
Welfare for the treatment of small-cell lung cancer (SCLC). The ODD was
supported by preliminary clinical data showing durable responses in patients
with extensive-stage SCLC (ES-SCLC) who were treated with Ris-Rez in the phase
I ARTEMIS-001 clinical trial.(( 1  (#_edn1) )) This is the sixth regulatory
designation for Ris-Rez, which is being developed in a range of solid tumours,
including lung, prostate and colorectal cancers.

 

Lung cancer is the second most common cancer in Japan, and SCLC makes up
10-15% of cases. 2  (#_edn2) (, 3  (#_edn3) ) Of patients with SCLC, 70% have
ES-SCLC, meaning the cancer has spread throughout one or both lungs and/or to
other parts of the body.(( 4  (#_edn4) )) ES-SCLC is an aggressive and
difficult-to-treat cancer with limited treatment options and poor long-term
survival. Most patients with ES-SCLC relapse after initial treatment and the
median overall survival with standard-of-care for these patients is
approximately 8 months. 5  (#_edn5)

 

About Ris-Rez

Ris-Rez is a novel investigational B7-H3-targeted antibody-drug conjugate
composed of a fully human anti-B7-H3 monoclonal antibody covalently linked to
a topoisomerase inhibitor payload. GSK acquired exclusive worldwide rights
(excluding China's mainland, Hong Kong, Macau, and Taiwan) from Hansoh Pharma
to progress clinical development and commercialisation of Ris-Rez. GSK's
global phase III trial (NCT07099898) for Ris-Rez in relapsed ES-SCLC began in
August 2025.

 

Regulatory designations received for Ris-Rez to date include ODDs from the US
Food and Drug Administration (FDA) in SCLC and the European Medicines Agency
(EMA) in a category of cancer that includes SCLC, called pulmonary
neuroendocrine carcinoma; Priority Medicines (PRIME) Designation from the EMA
for relapsed or refractory ES-SCLC; and Breakthrough Therapy Designations for
relapsed or refractory ES-SCLC and relapsed or refractory osteosarcoma from
the US FDA.(( 6  (#_edn6) ))(,( 7  (#_edn7) )),( 8  (#_edn8) )

 

About GSK

GSK is a global biopharma company with a purpose to unite science, technology,
and talent to get ahead of disease together. Find out more at www.gsk.com
(https://www.gsk.com) .

 

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Cautionary statement regarding forward-looking statements

GSK cautions investors that any forward-looking statements or projections made
by GSK, including those made in this announcement, are subject to risks and
uncertainties that may cause actual results to differ materially from those
projected. Such factors include, but are not limited to, those described in
the "Risk Factors" section in GSK's Annual Report on Form 20-F for 2025.

 

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 1  (#_ednref1) Wang J, et al. Presented at IASLC WCLC 2024.

 2  (#_ednref2) GLOBOCAN 2022
https://gco.iarc.who.int/media/globocan/factsheets/populations/392-japan-fact-sheet.pdf
(https://gco.iarc.who.int/media/globocan/factsheets/populations/392-japan-fact-sheet.pdf)
Accessed 9 March 2026

 3  (#_ednref3) Japan Lung Cancer Society. Lung Cancer Clinical Practice
Guidelines 2025 Edition.  Available at
https://www.haigan.gr.jp/publication/guideline/examination/2025/
(https://www.haigan.gr.jp/publication/guideline/examination/2025/)

 4  (#_ednref4) SEER Explorer Surveillance Research Program, National Cancer
Institute, accessed 27 October 2025.

 5  (#_ednref5) G. Mountzios, et al. Tarlatamab in small-cell lung cancer
after platinum-based chemotherapy. N Engl J Med, 393 (2025), pp. 349-361. DOI:
10.1056/NEJMoa2502099

 6  (#_ednref6) GSK. GSK receives US FDA Breakthrough Therapy Designation for
its B7-H3-targeted antibody-drug conjugate in relapsed or refractory
extensive-stage small-cell lung cancer. Available at:
https://www.gsk.com/en-gb/media/press-releases/gsk-receives-us-fda-breakthrough-therapy-designation/
(https://www.gsk.com/en-gb/media/press-releases/gsk-receives-us-fda-breakthrough-therapy-designation/)
.

 7  (#_ednref7) GSK. GSK's B7-H3-targeted antibody-drug conjugate, GSK'227,
receives EMA Priority Medicines (PRIME) Designation in relapsed
extensive-stage small-cell lung cancer. Available at:
https://www.gsk.com/en-gb/media/press-releases/b7-h3-targeted-antibody-drug-conjugate-receives-ema-priority-medicines-designation-in-relapsed-extensive-stage-small-cell-lung-cancer/
(https://www.gsk.com/en-gb/media/press-releases/b7-h3-targeted-antibody-drug-conjugate-receives-ema-priority-medicines-designation-in-relapsed-extensive-stage-small-cell-lung-cancer/)
.

 8  (#_ednref8) GSK. GSK's B7-H3-targeted antibody-drug conjugate, GSK'227,
receives US FDA Breakthrough Therapy Designation in late-line relapsed or
refractory osteosarcoma. Available at:
https://www.gsk.com/en-gb/media/press-releases/gsk-b7-h3-targeted-antibody-drug-conjugate-gsk227-receives-us-fda-breakthrough-therapy-designation-in-late-line-relapsed-or-refractory-osteosarcoma/
(https://www.gsk.com/en-gb/media/press-releases/gsk-b7-h3-targeted-antibody-drug-conjugate-gsk227-receives-us-fda-breakthrough-therapy-designation-in-late-line-relapsed-or-refractory-osteosarcoma/)
.

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