Secura Bio Announces Final Patient Enrolled in the COPIKTRA® (duvelisib) (PRIMO) Study in Relapsed and Refractory Peripheral T-cell Lymphoma
Secura Bio Announces Final Patient Enrolled in the COPIKTRA® (duvelisib) (PRIMO) Study in Relapsed and Refractory Peripheral T-cell Lymphoma
SUMMERLIN, Nev., Feb. 9, 2022 /PRNewswire/ -- Secura Bio, Inc. (Secura Bio) - (), an integrated pharmaceutical company dedicated to the worldwide development and commercialization of impactful oncology therapies, today announced that it completed enrollment on February 1, 2022, in the PRIMO study. PRIMO is evaluating COPIKTRA for the treatment of adult patients with relapsed or refractory (r/r) Peripheral T-cell Lymphoma (PTCL) and has enrolled a total of 157 patients.
內華達州薩默林，2022年2月9日/美通社/--Secura Bio，Inc.(Secura Bio)-()是一家致力於在全球範圍內開發和商業化有效腫瘤療法的綜合製藥公司，今天宣佈它已於2022年2月1日，在Primo研究中。Primo正在評估COPIKTRA用於治療復發或難治性(r/r)外周T細胞淋巴瘤(PTCL)的成人患者，並已招募了總共157名患者。
COPIKTRA is an oral inhibitor of phosphoinositide 3-kinase (PI3K), and the first approved dual inhibitor of PI3K-delta and gamma pathways, which are involved in the proliferation and sustenance of malignant cells. COPIKTRA monotherapy has received Fast Track status for the treatment of PTCL patients who have received at least one prior therapy. Additionally, COPIKTRA has received an Orphan Drug Designation for use in the treatment of T-cell lymphomas. Treatment of T-cell lymphomas is a disease category for which COPIKTRA is not currently indicated.
COPIKTRA是一種口服磷脂酰肌醇3-激酶(PI3K)抑制劑，也是第一個被批准的PI3K-δ和γ通路的雙重抑制劑，這兩個途徑與惡性腫瘤細胞的增殖和維持有關。COPIKTRA單一療法已獲得快速通道狀態，用於治療先前至少接受過一次治療的PTCL患者。此外，COPIKTRA還獲得了用於治療T細胞淋巴瘤的孤兒藥物稱號。T細胞淋巴瘤的治療是一種目前沒有COPIKTRA指徵的疾病類別。
The PRIMO study is a global, multi-center, open-label, parallel cohort, Phase 2 study. In the dose optimization portion of the study, 33 patients were randomized to receive COPIKTRA 25mg twice daily (Cohort 1) or COPIKTRA 75mg twice daily continuously (Cohort 2) until progressive disease (PD) or unacceptable toxicity. Based on the dose optimization results, an expansion group of 124 patients was added in which COPIKTRA is dosed at 75mg twice daily for two cycles, followed by 25mg twice daily, until PD or unacceptable toxicity. The primary endpoint of the expansion phase of the study is overall response rate (ORR; complete response [CR] + partial response) as determined by an independent review committee (IRC). Secondary endpoints include additional efficacy measures including duration of response (DOR), progression free survival, pharmacokinetics, and safety.
PRIMO研究是一項全球性、多中心、開放標籤、平行隊列的2期研究。在研究的劑量優化部分，33名患者隨機接受COPIKTRA每日兩次25毫克(隊列1)或COPIKTRA 75毫克每天連續兩次(隊列2)的治療，直到病情進展或出現不可接受的毒性。根據劑量優化的結果，增加了124例患者的擴展組，COPIKTRA劑量為75 mg，每日2次，共2個週期，然後每天2次，25 mg，直到帕金森病或不可接受的毒性。研究擴展階段的主要終點是總體響應率(ORR；Complete Response[鉻]+部分響應)，由獨立審查委員會(IRC)確定。次要終點包括額外的療效指標，包括反應持續時間(DOR)、無進展存活率、藥代動力學和安全性。
An interim analysis of the first 78 patients in the expansion phase, with a minimum follow-up of 6 months, was reported in December 2021 at the 63rd Annual Meeting of the American Society of Hematology (ASH) in Atlanta, Georgia. The study is ongoing and is expected to have enough events for the primary endpoint analysis later in 2022.
一項對第一批78名處於擴張期的患者進行的中期分析，至少隨訪6個月，於2021年12月在63年12月報道。研發在亞特蘭大舉行的美國血液學會(ASH)年會，佐治亞州。這項研究正在進行中，預計2022年晚些時候將有足夠的事件用於主要終點分析。
Interim results included an ORR by IRC assessment of 50% (39/78 pts) and a CR rate of 32.1% (25/78), with a median DOR of 233 days (range, 1-420+). Patients had a median of 3 (range, 1-7) prior therapeutic regimens and included the following PTCL subtypes: PTCL NOS (53.8%), ALCL (14.1%), AITL (26.0%) and Other (0.5%). Eighteen percent of patients remain on therapy; 47.4% discontinued due to PD, 6.4% discontinued for stem cell transplant, and 19.2% discontinued due to unacceptable toxicity.
中期結果包括IRC評估的ORR為50%(39/78分)，CR率為32.1%(25/78分)，中位DOR為233天(範圍1-420+)。患者既往治療方案的中位數為3(範圍1~7)，包括以下PTCL亞型：PTCL NOS(53.8%)、ALCL(14.1%)、AITL(26.0%)和其他(0.5%)。18%的患者仍在接受治療；47.4%的患者因帕金森病而停止治療，6.4%的患者停止幹細胞移植，19.2%的患者因不可接受的毒性而停止治療。
Overall, the safety profile was consistent with that seen in previous studies. In this analysis the most frequent > Grade 3 adverse events seen were neutropenia (21.8%), ALT/AST increased (24.4%/ 21.8%), rash (7.7%), lymphocyte count decreased (7.7%), and sepsis (6.4%). ALT and/or AST elevations were the most common treatment-emergent AEs leading to treatment discontinuations (N=12, 15.4%).
總體而言，安全性情況與之前的研究一致。在這種分析中，最常見的>3級不良反應為中性粒細胞減少(21.8%)、ALT/AST升高(24.4%/21.8%)、皮疹(7.7%)、淋巴細胞計數下降(7.7%)和膿毒症(6.4%)。ALT和/或AST升高是最常見的治療急症不良反應，導致治療中斷(N=12，15.4%)。
Shortly following the presentation of these data at ASH, COPIKTRA was included in the National Comprehensive Cancer Network® T-Cell Lymphoma Guidelines® (Version 1.2022, 12/22/21) as a Category 2A designated option for the treatment of all subtypes of r/r PTCL.
在ASH上展示這些數據後不久，COPIKTRA就被納入了國家綜合癌症網絡®T細胞淋巴瘤指南® (版本1.2022，12/22/21)作為治療r/rPTCL所有亞型的2A類指定選項。
"Secura Bio is dedicated to the development of COPIKTRA for the treatment of T-cell malignancies because these patients often have limited therapeutic options and generally poor outcomes. In addition to the treatment of r/r PTCL patients, we are exploring a wide range of development options for T-cell malignancies, including earlier line use as a single-agent or in combinations with other mechanisms of action." Said Dr. David Cohan, Chief Medical Officer of Secura Bio.
賽庫拉生物公司致力於開發用於治療T細胞惡性腫瘤的COPIKTRA，因為這些患者的治療選擇往往有限，結果通常很差。除了治療r/r PTCL患者外，我們還在探索T細胞惡性腫瘤的廣泛開發選擇，包括早期作為單一藥物使用或與其他作用機制結合使用。“賽庫拉生物公司(Secura Bio)首席醫療官大衞·科漢(David Cohan)博士説。
"Secura Bio in the last few months has sharpened its overall development focus to a very great extent on the potential of COPIKTRA in the treatment of T-cell malignancies. We believe that this patient population has the potential to benefit greatly based on these actions." Said Joseph M. Limber, President and CEO of Secura Bio.
在過去的幾個月裏，賽庫拉生物公司在很大程度上將其總體開發重點放在了COPIKTRA在治療T細胞惡性腫瘤方面的潛力上。我們相信，這一患者羣體有可能從這些行動中受益良多。“賽庫拉生物公司總裁兼首席執行官約瑟夫·M·林伯説。
About Secura Bio, Inc.
關於賽庫拉生物公司
Secura Bio is an integrated, commercial-stage pharmaceutical company dedicated to the worldwide commercialization of significant oncology therapies for physicians and their patients. For more information on Secura Bio, please visit .
賽庫拉生物公司是一家綜合性的商業階段製藥公司，致力於為醫生和患者提供重要的腫瘤學療法的全球商業化。有關賽庫拉生物公司的更多信息，請訪問。
About COPIKTRA (duvelisib)
關於COPIKTRA(Duvelisib)
COPIKTRA is an oral inhibitor of phosphoinositide 3-kinase (PI3K), and the first US approved dual inhibitor of PI3K-delta and PI3K-gamma, two enzymes known to help support the growth and survival of malignant cells. PI3K signaling may lead to the proliferation of malignant cells and is thought to play a role in the formation and maintenance of a supportive tumor microenvironment. COPIKTRA is indicated in the United States for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after at least two prior therapies. COPIKTRA is also being developed for the treatment of peripheral T-cell lymphoma (PTCL), for which it has received Fast Track status in the United States and is being investigated in combination with other agents through investigator-sponsored studies. For more information on COPIKTRA, please visit . Information about duvelisib clinical trials can be found on .
COPIKTRA是一種口服磷脂酰肌醇3-激酶(PI3K)抑制劑，也是美國批准的第一個PI3K-δ和PI3K-γ雙重抑制劑，這兩種酶已知有助於支持惡性腫瘤細胞的生長和存活。PI3K信號可能導致惡性腫瘤細胞的增殖，並被認為在支持性腫瘤微環境的形成和維持中發揮作用。COPIKTRA在美國被用於治療經過至少兩次治療後復發或難治性慢性淋巴細胞白血病/小淋巴細胞性淋巴瘤(CLL/SLL)的成人患者。COPIKTRA也正在被開發用於治療外周T細胞淋巴瘤(PTCL)，它已經在美國獲得了快車道地位，並正在通過研究人員贊助的研究與其他藥物一起進行研究。有關COPIKTRA的更多信息，請訪問。有關duvelisib臨牀試驗的信息可以在上找到。
IMPORTANT SAFETY INFORMATION ABOUT COPIKTRA
關於COPIKTRA的重要安全信息
WARNING: FATAL AND SERIOUS TOXICITIES: INFECTIONS, DIARRHEA OR COLITIS, CUTANEOUS REACTIONS, and PNEUMONITIS
警告：致命和嚴重的毒性：感染、腹瀉或結腸炎、皮膚反應和肺炎
See full prescribing information for complete boxed warning
有關完整的盒裝警告，請參閲完整的處方信息
- Fatal and/or serious infections occurred in 31% (4% fatal) of COPIKTRA-treated patients. Monitor for signs and symptoms of infection. Withhold COPIKTRA if infection is suspected.
- Fatal and/or serious diarrhea or colitis occurred in 18% (<1% fatal) of COPIKTRA-treated patients. Monitor for the development of severe diarrhea or colitis. Withhold COPIKTRA.
- Fatal and/or serious cutaneous reactions occurred in 5% (<1% fatal) of COPIKTRA-treated patients. Withhold COPIKTRA.
- Fatal and/or serious pneumonitis occurred in 5% (<1% fatal) of COPIKTRA-treated patients. Monitor for pulmonary symptoms and interstitial infiltrates. Withhold COPIKTRA.
- 接受COPIKTRA治療的患者中有31%(4%)發生致命和/或嚴重感染。監測感染的體徵和症狀。如果懷疑感染，請扣留COPIKTRA。
- 發生致命和/或嚴重腹瀉或結腸炎的比例為18%(
- 致命和/或嚴重的皮膚反應發生率為5%(
- 致命性和/或嚴重肺炎的發生率為5%(
INDICATIONS AND USAGE
適應症和用法
COPIKTRA is a kinase inhibitor indicated for the treatment of adult patients with:
COPIKTRA是一種激酶抑制劑，用於治療患有以下疾病的成人患者：
Relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two prior therapies.
複發性或難治性慢性淋巴細胞性白血病(CLL)或小淋巴細胞性淋巴瘤(SLL)，在至少兩次治療後復發或難治性慢性淋巴細胞白血病(CLL)或小淋巴細胞性淋巴瘤(SLL)。
WARNINGS AND PRECAUTIONS
警告及預防措施
- Hepatotoxicity: Monitor hepatic function.
- Neutropenia: Monitor blood counts.
- Embryo-Fetal toxicity: COPIKTRA can cause fetal harm. Advise patients of potential risk to a fetus and to use effective contraception.
- 肝毒性：監測肝功能。
- 中性粒細胞減少症：監測血細胞計數。
- 胚胎-胎兒毒性：COPIKTRA會對胎兒造成傷害。建議患者注意胎兒的潛在風險，並使用有效的避孕措施。
ADVERSE REACTIONS
不良反應
The most common adverse reactions (≥20%) are diarrhea or colitis, neutropenia, rash, fatigue, pyrexia, cough, nausea, upper respiratory infection, pneumonia, musculoskeletal pain, and anemia.
最常見的不良反應(≥20%)是腹瀉或結腸炎、中性粒細胞減少、皮疹、乏力、發熱、咳嗽、噁心、上呼吸道感染、肺炎、肌肉骨骼疼痛和貧血。
DRUG INTERACTIONS
藥物相互作用
- CYP3A inducers: Avoid co-administration with strong or moderate CYP3A inducers.
- CYP3A inhibitors: Monitor for COPIKTRA toxicities when co-administered with strong or moderate CYP3A inhibitors. Reduce COPIKTRA dose to 15 mg twice daily when co-administered with strong CYP3A4 inhibitors.
- CYP3A substrates: Monitor for signs of toxicities when co-administering COPIKTRA with sensitive CYP3A substrates.
- CYP3A誘導劑：避免與強或中度CYP3A誘導劑合用。
- CYP3A抑制劑：當與強或中度的CYP3A抑制劑聯合使用時，監測COPIKTRA的毒性。當與強的CYP3A4抑制劑聯合使用時，將COPIKTRA劑量減少到15毫克，每天兩次。
- CYP3A底物：當聯合使用COPIKTRA和敏感的CYP3A底物時，監測毒性跡象。
USE IN SPECIFIC POPULATIONS
在特定人羣中使用
Lactation: Advise women not to breastfeed.
哺乳：建議女性不要母乳餵養。
Please click here to see full Prescribing Information, including Boxed WARNING, for COPIKTRA (duvelisib).
請單擊此處查看COPIKTRA(Duvelisib)的完整説明信息，包括方框警告。
About Peripheral T-cell Lymphoma
關於外周T細胞淋巴瘤
Peripheral T-cell lymphoma (PTCL) is a rare, aggressive type of non-Hodgkin lymphoma (NHL) that develops in mature white blood cells called "T cells" and "natural killer (NK) cells"1 which circulate through the bloodstream and lymphatic system. PTCL accounts for between 10-15% of all non-Hodgkin lymphomas (NHLs) and generally affects people aged 60 years and older. Although there are many different subtypes of peripheral T-cell lymphoma, they often present in a similar way, with widespread, enlarged, typically painless lymph nodes in the neck, armpit, and/or groin. There are currently no well-established standards of care for patients with relapsed or refractory disease.
外周T細胞淋巴瘤(PTCL)是一種罕見的侵襲性非霍奇金淋巴瘤(NHL)，它發生在被稱為“T細胞”和“自然殺傷細胞”的成熟白細胞中。1它們在血液和淋巴系統中循環。PTCL佔所有非霍奇金淋巴瘤(NHL)的10-15%，一般影響60歲以上的人。雖然外周T細胞淋巴瘤有許多不同的亞型，但它們通常以相似的方式出現，在頸部、腋窩和/或腹股溝有廣泛的、腫大的、典型的無痛淋巴結。目前，對於復發或難治性疾病的患者，沒有完善的護理標準。
1-800-9SECURA (1-844-973-2872).
1-800-9 SECURA(1-844-973-2872)。
Related Links
相關鏈接
SOURCE Secura Bio, Inc.
來源：Secura Bio，Inc.
譯文內容由第三人軟體翻譯。