SHANGHAI and SAN FRANCISCO and CAMBRIDGE, Mass., Sept. 20, 2022 (GLOBE NEWSWIRE) — Zai Lab Restricted (NASDAQ: ZLAB; today techs HKEX: 9688), a patient-focused, progressive, commercial-stage, international biopharmaceutical firm, will current a poster that includes initiation timing evaluation from the Part 3 PRIME research of ZEJULA® (niraparib) as upkeep remedy on the upcoming 2022 Worldwide Gynecologic Most cancers Society (ICGS) Annual Assembly.
This post-hoc evaluation of the PRIME Part 3 research evaluated adults with newly identified superior ovarian most cancers who responded to first-line platinum-based chemotherapy, they usually had been randomized to obtain niraparib upkeep remedy or placebo inside 12 weeks after chemotherapy completion. The outcomes are as follows:
- For sufferers who acquired niraparib remedy lower than 9 weeks after chemotherapy completion, the median progression-free survival (PFS) (95% CI) was measured at 29.4 months with niraparib versus 8.3 months with placebo today techs (HR =0.31; 95% CI, 0.20–0.48).
- For sufferers who acquired niraparib at 9 – 12 weeks after chemotherapy completion, the median PFS was 24.7 months with niraparib today techs versus 10.8 months with placebo (HR=0.60; 95% CI, 0.41–0.89).
- The initiation timing of niraparib upkeep remedy had no vital impression on its security profile.
This subgroup evaluation offers proof to help the initiation of niraparib upkeep remedy in sufferers with newly identified superior ovarian most cancers inside 12 weeks after chemotherapy completion.
“We’re excited to be presenting on the 2022 Worldwide Gynecologic Most cancers Society Annual Assembly exhibiting these outcomes improved medical efficacy when niraparib upkeep remedy is initiated inside 12 weeks after chemotherapy in sufferers with superior ovarian most cancers,” mentioned Alan Sandler, M.D., President and Head of International Growth, Oncology, Zai Lab. “This research additional helps ZEJULA as an essential upkeep remedy remedy after platinum-based chemotherapy in individuals with superior ovarian most cancers.”
“This PRIME research evaluation will assist help medical observe in treating superior ovarian most cancers in China, exhibiting niraparib prolonged progression-free survival when upkeep remedy begins inside 12 weeks after chemotherapy,” mentioned Jing Wang, M.D., Director of the Early Scientific Analysis Middle, Hunan Most cancers Hospital. “Since a majority of girls face recurrence of superior ovarian most cancers after chemotherapy, this research helps niraparib upkeep remedy having a major medical profit in extending progression-free survival in comparison with placebo.”
Particulars relating to the e-poster presentation at IGCS 2022 are as follows:
|Summary quantity: 876
Title: Affect of initiation timing of niraparib upkeep remedy in newly identified superior ovarian most cancers
Speaker: Jing Wang, M.D., Hunan Most cancers Hospital
Date: September 29-October 1, 2022
About PRIME Examine
The totally powered Part 3 PRIME research was evaluated in 384 superior ovarian most cancers sufferers who had been in an entire or partial response to platinum-based chemotherapy and who had been randomized 2:1 to obtain ZEJULA or placebo as upkeep remedy. The research evaluated the efficacy of ZEJULA as a upkeep remedy, with the first endpoint of PFS as assessed by blinded impartial central overview. The beginning dose was individualized at 200 mg apart from these sufferers with a baseline physique weight ≥ 77kg and a platelet depend ≥ 150K/μL, by which case the beginning dose was 300 mg.
About Ovarian Most cancers
Ovarian most cancers is without doubt one of the most typical gynecologic cancers in China, with over 55,000 newly identified circumstances and 37,000 deaths in China yearly1. Whereas platinum-based chemotherapy is efficient at inducing an preliminary response in ovarian most cancers, the illness will recur within the majority of girls. New brokers that delay the length of response following platinum-based remedy and delay the relapse of ovarian most cancers will profit sufferers with ovarian most cancers in China.
1 Globocan 2020.
About ZEJULA (niraparib)
ZEJULA (niraparib) is an oral, once-daily poly (ADP-ribose) polymerase (PARP) inhibitor indicated as monotherapy for the upkeep remedy of grownup sufferers with newly analysis and platinum-sensitive relapsed superior and recurrent epithelial ovarian, fallopian tube, or main peritoneal most cancers who’re in response (full or partial) to platinum-based chemotherapy.
Along with the PRIME research, Zai Lab has accomplished a number of research in Chinese language sufferers with ovarian most cancers:
- In September 2020, Zai Lab introduced that ZEJULA demonstrated a major PFS profit with an improved security profile within the firm’s Part 3 NORA research of ZEJULA as upkeep remedy for Chinese language sufferers with platinum-sensitive, recurrent ovarian most cancers, no matter biomarker standing.
- A Part 1 pharmacokinetic research of ZEJULA was carried out in Chinese language sufferers with ovarian most cancers.
Zai Lab has a collaboration and license settlement with GSK for the event and commercialization of ZEJULA (independently manufactured by Zai Lab) in mainland China, Hong Kong, and Macau.
About Zai Lab
Zai Lab Restricted (NASDAQ: ZLAB; HKEX: 9688) is an progressive, research-based, commercial-stage biopharmaceutical firm primarily based in China and the USA targeted on bringing transformative medicines for oncology, autoimmune issues, infectious ailments, and neurological issues to sufferers in China and world wide. Our purpose is to leverage our competencies and assets to positively impression human well being worldwide.
For added details about Zai Lab, together with our merchandise, enterprise actions and partnerships, analysis, and different occasions or developments, please go to www.zailaboratory.com or observe us at www.twitter.com/ZaiLab_Global.
Zai Lab Ahead-Wanting Statements
This press launch comprises forward-looking statements regarding our Part 3 PRIME research of ZEJULA® (niraparib); medical growth applications; medical trial knowledge, knowledge readouts, and shows; dangers and uncertainties related to drug growth and commercialization; and the potential advantages, security, and efficacy of our collaboration companions’ merchandise and of our pipeline therapies. All statements, aside from statements of historic reality, included on this press launch are forward-looking statements, and could be recognized by phrases akin to “intention,” “anticipate,” “consider,” “may,” “estimate,” “count on,” “forecast,” “purpose,” “intend,” “could,” “plan,” “attainable,” “potential,” “will,” “would,” and different related expressions. Such statements represent forward-looking statements throughout the which means of the Personal Securities Litigation Reform today techs Act of 1995. Ahead-looking statements are usually not ensures or assurances of future efficiency. Ahead-looking statements are primarily based on our expectations and assumptions as of the date of this press launch and are topic to inherent uncertainties, dangers, and modifications in circumstances which will differ materially from these contemplated by the forward-looking statements. We could not really obtain the plans, perform the intentions, or meet the expectations or projections disclosed in our forward-looking statements, and you shouldn’t place undue reliance on these forward-looking statements. Precise outcomes could differ materially from these indicated by forward-looking statements on account of varied essential components, together with however not restricted to (1) our means to efficiently commercialize and generate income from our accredited merchandise, (2) our means to acquire funding for our operations and enterprise initiatives, (3) the outcomes of our medical and pre-clinical growth of our product candidates, (4) the content material and timing of choices today techs made by the related regulatory authorities relating to regulatory approvals of our product candidates, (5) the consequences of the novel coronavirus (COVID-19) pandemic, together with any authorities actions or lockdown measures taken in response, on our enterprise and basic financial, regulatory, and political situations, (6) dangers associated to doing enterprise in China, and (7) different components recognized in our most up-to-date annual and quarterly stories and in different stories we have now filed with the U.S. Securities and Alternate Fee. We anticipate that subsequent occasions and developments will trigger our expectations and assumptions to vary, and we undertake no obligation to replace or revise any forward-looking statements, whether or not on account of new info, future occasions, or in any other case, besides as could also be required by legislation. These forward-looking statements shouldn’t be relied upon as representing our views as of any date subsequent to the date of this press launch.
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For extra info, please contact:
Investor Relations: Lina Zhang
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