浩鼎乳癌新藥OBI-822臨床數據未演先轟動!美國臨床腫瘤醫學會(ASCO)率先發表的論文摘要,據了解,已吸引美國、歐洲及部分亞洲地區廣為新聞報導和...
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首日點閱人數逾9千萬次 浩鼎新藥論文摘要 國際關注
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Re: 首日點閱人數逾9千萬次 浩鼎新藥論文摘要 國際關注
還是沒還被限制出境的翁啟惠一個公道
如果當時解盲失敗連跌幾根的肅殺氣氛中 翁連記者訪問都不敢說一兩句明明符合專業、還很保守點到為止的話 股價可能就跟那些人詛咒的連跌十九隻停板 700股價剩一百兩百
融資散戶下場 就是補到沒錢了還繼續跌停 最後跌停打開那天被斷頭 欠號子一屁股債...然後眼睜睜看著股價又飆上四百五百...
不知會有多少人被害死 剩下的被氣到剩半條命
那些說翁不應秉持專業講實話 應該讓股價跌十九隻停板的國民黨立委跟附和的人 你們為了鬥爭 沒人性無視專業至此
如果當時解盲失敗連跌幾根的肅殺氣氛中 翁連記者訪問都不敢說一兩句明明符合專業、還很保守點到為止的話 股價可能就跟那些人詛咒的連跌十九隻停板 700股價剩一百兩百
融資散戶下場 就是補到沒錢了還繼續跌停 最後跌停打開那天被斷頭 欠號子一屁股債...然後眼睜睜看著股價又飆上四百五百...
不知會有多少人被害死 剩下的被氣到剩半條命
那些說翁不應秉持專業講實話 應該讓股價跌十九隻停板的國民黨立委跟附和的人 你們為了鬥爭 沒人性無視專業至此
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Re: 首日點閱人數逾9千萬次 浩鼎新藥論文摘要 國際關注
Randomized phase II/III trial of active immunotherapy with OPT-822/OPT-821 in patients with metastatic breast cancer.
Abstract:
Background: Globo H is a glycolipid that is highly expressed in breast cancer (BC). Active immunotherapy with OPT-822, a Globo H–KLH conjugate, and the adjuvant OPT-821 in 2 phase (Ph) I trials, induced Globo H specific antibodies which could mediate in vitro binding and cytotoxicity to Globo H expressing BC cells.
Methods: In this international, randomized, double-blind, placebo-controlled Ph II/III trial (NCT01516307), patients (pts) with metastatic BC who had ≤ 2 events of progressive disease (PD) and who achieved at least stable disease (SD) after ≥ 1 anticancer regimen were randomized 2:1 to receive subcutaneous OPT-822 (30 μg Globo H)/OPT-821 (100 μg) or control (PBS) on weeks 1, 2, 3, 5, 9, 13, 17, 25, and 37 or until PD, in combination with low-dose cyclophosphamide (300 mg/m2). Hormone therapy was allowed. The primary and secondary efficacy end points were progression-free survival (PFS) and overall survival (OS), correlated with humoral antibody response.
Results: 349 pts were randomized, 348 received study drug (ITT), 168 (48%) received all 9 injections. 70% had hormone receptor positive BC, 13% were triple negative, and 62% received hormone therapy. No difference was observed in PFS (HR, 0.96 [95% CI, 0.74-1.25] P = .77) or in interim OS (HR, 0.79 [95% CI, 0.51-1.22] P = .29). However, PFS and OS were significantly improved in the 50% of pts who developed a Globo H specific IgG response to OPT-822/OPT-821 with a titer ≥ 1:160 at any time during treatment vs control (HR, 0.71 [95% CI, 0.52-0.97] P = .029 for PFS; HR, 0.57 [95% CI, 0.33-0.97] P = .04 for OS) and vs nonresponders (HR, 0.52 [95% CI, 0.37-0.71] P< .0001 for PFS; HR, 0.52 [95% CI, 0.29-0.92] P = .025 for OS), adjusted for baseline disease status/hormone use. In a time-dependent Cox model, PFS was improved in pts who received all 9 injections of OPT vs control (HR, 0.66 [95% CI, 0.42-1.01] P= .057). OPT-822/OPT-821 was well tolerated; the most common drug-related adverse event was grade 1/2 injection reaction.
Conclusion: Vaccination with OPT-822/OPT-821 did not improve PFS in the ITT; however, PFS and interim OS were significantly improved in pts who developed an immune response to the vaccine. These subgroup data will be used to design a definitive Ph III trial.
http://abstract.asco.org/176/AbstView_176_168513.html
Abstract:
Background: Globo H is a glycolipid that is highly expressed in breast cancer (BC). Active immunotherapy with OPT-822, a Globo H–KLH conjugate, and the adjuvant OPT-821 in 2 phase (Ph) I trials, induced Globo H specific antibodies which could mediate in vitro binding and cytotoxicity to Globo H expressing BC cells.
Methods: In this international, randomized, double-blind, placebo-controlled Ph II/III trial (NCT01516307), patients (pts) with metastatic BC who had ≤ 2 events of progressive disease (PD) and who achieved at least stable disease (SD) after ≥ 1 anticancer regimen were randomized 2:1 to receive subcutaneous OPT-822 (30 μg Globo H)/OPT-821 (100 μg) or control (PBS) on weeks 1, 2, 3, 5, 9, 13, 17, 25, and 37 or until PD, in combination with low-dose cyclophosphamide (300 mg/m2). Hormone therapy was allowed. The primary and secondary efficacy end points were progression-free survival (PFS) and overall survival (OS), correlated with humoral antibody response.
Results: 349 pts were randomized, 348 received study drug (ITT), 168 (48%) received all 9 injections. 70% had hormone receptor positive BC, 13% were triple negative, and 62% received hormone therapy. No difference was observed in PFS (HR, 0.96 [95% CI, 0.74-1.25] P = .77) or in interim OS (HR, 0.79 [95% CI, 0.51-1.22] P = .29). However, PFS and OS were significantly improved in the 50% of pts who developed a Globo H specific IgG response to OPT-822/OPT-821 with a titer ≥ 1:160 at any time during treatment vs control (HR, 0.71 [95% CI, 0.52-0.97] P = .029 for PFS; HR, 0.57 [95% CI, 0.33-0.97] P = .04 for OS) and vs nonresponders (HR, 0.52 [95% CI, 0.37-0.71] P< .0001 for PFS; HR, 0.52 [95% CI, 0.29-0.92] P = .025 for OS), adjusted for baseline disease status/hormone use. In a time-dependent Cox model, PFS was improved in pts who received all 9 injections of OPT vs control (HR, 0.66 [95% CI, 0.42-1.01] P= .057). OPT-822/OPT-821 was well tolerated; the most common drug-related adverse event was grade 1/2 injection reaction.
Conclusion: Vaccination with OPT-822/OPT-821 did not improve PFS in the ITT; however, PFS and interim OS were significantly improved in pts who developed an immune response to the vaccine. These subgroup data will be used to design a definitive Ph III trial.
http://abstract.asco.org/176/AbstView_176_168513.html
'We are all just prisoners here of our own device'
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Re: 首日點閱人數逾9千萬次 浩鼎新藥論文摘要 國際關注
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