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2019年9月29日，加科思自主研发、具有全球知识产权的小分子口服抗肿瘤药JAB-3312在中国获得临床许可，将于近期在中、美同步开展临床试验，这也是加科思继JAB-3068后第二个同时在中、美两国获得临床许可的药物。 JAB-3312将用于治疗携带KRAS G12突变、BRAF Class3、NF1LoF、以及RTK突变、扩增或重排等基因型异常的实体瘤患者，包括但不限于非小细胞肺癌、结直肠癌、胰腺癌、食管鳞癌、头颈部鳞癌。同时JAB-3312单药或JAB-3312联合PD-1抗体，也可用于经PD-1/PD-L1抗体治疗失败或耐药的非小细胞肺癌、结直肠癌、膀胱癌、三阴性乳腺癌患者等。 伴随JAB-3068进入临床IIa期，JAB-3312临床试验的开展将为患者提供更多的治疗选择。 信息来源：加科思 Phase III PEMPHIX Study Shows Genentech’s Rituxan (Rituximab) Superior to Mycophenolate Mofetil in Patients With Pemphigus Vulgaris 40% of patients with pemphigus vulgaris (PV) achieved sustained complete remission, without the use of steroids for 16 weeks or more, when treated with Rituxan compared to 9.5% of patients on mycophenolate mofetil Study reinforces efficacy and safety of Rituxan for treatment of PV, a rare autoimmune condition characterized by blistering of the skin and mucous membranes Full data of the 52-week treatment period presented at 28th Congress of the European Academy of Dermatology and Venereology (EADV) in Madrid South San Francisco, CA -- October 13, 2019 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced data from the Phase III PEMPHIX study evaluating the efficacy and safety of Rituxan® (rituximab) compared to mycophenolate mofetil (MMF) in adults with moderate to severe pemphigus vulgaris (PV). The study met the primary endpoint at week 52 and demonstrated that Rituxan is superior to MMF, with 40.3% of patients treated with Rituxan achieving sustained complete remission (CR) without the use of steroids for 16 consecutive weeks or more, compared to 9.5% in the MMF arm (p<0.0001). All secondary endpoints were statistically significant in favor of Rituxan: lower cumulative oral corticosteroid dose (mean difference: 1595 mg; p=0.0005), fewer flares (6 vs. 44, p<0.0001), a greater likelihood of sustained CR (hazard ratio [HR]=4.83; p=0.0003), a lesser likelihood of flare (HR=0.15; p<0.0001) and a greater improvement in the Dermatology Life Quality Index (DLQI) at week 52 (estimated mean change from baseline -8.87 vs. -6.00, p=0.0012) compared to the MMF arm. Adverse events were generally consistent with those seen in previous Rituxan clinical studies in PV and other approved autoimmune indications. Results were presented as a late-breaking oral presentation at the 28th Congress of the European Academy of Dermatology and Venereology in Madrid, Spain on October 12 at 9:00 a.m. – 9:15 a.m. CEST (Presentation D3T01.1C). “The approval of Rituxan for the treatment of pemphigus vulgaris was the first major advancement in the treatment of this rare, serious disease in more than 60 years,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “The PEMPHIX study showed that 40% of people in the study could achieve complete remission from painful blistering without the need for corticosteroids for 16 weeks or more and that Rituxan may be a superior treatment option to mycophenolate mofetil.” The study is ongoing, with patients participating in a 48-week safety follow-up period after treatment completion or discontinuation. PV is a rare, serious and potentially life-threatening condition characterized by progressive painful blistering of the skin and mucous membranes. MMF is an unapproved, commonly used treatment for PV that is recommended in published treatment guidelines. Rituxan became the first biologic therapy for PV when it was approved by the U.S. Food and Drug Administration (FDA) in June 2018 and the European Commission in March 2019. These approvals were based on data from the Roche-supported Ritux 3 clinical trial. The PEMPHIX study provides additional clinical evidence of the effectiveness of Rituxan for PV. About the PEMPHIX Study PEMPHIX is a Phase III, randomized, double-blind, double-dummy, active-comparator, parallel-arm, international, multicenter study (NCT02383589) designed to evaluate the efficacy and safety of Rituxan compared with mycophenolate mofetil (MMF) in patients with moderate to severe active pemphigus vulgaris requiring 60-120 mg/day oral prednisone (or equivalent). Participants were randomly assigned to receive Rituxan plus MMF placebo or Rituxan placebo plus MMF for 52 weeks, in combination with 60 or 80 mg oral prednisone, with the aim of tapering to 0 mg/day by week 24. Rituxan was administered at a dose of 1000 mg via intravenous (IV) infusion on day 1 and 15, with a repeat administration on days 168 and 182. MMF was administered at a dose of 2 grams orally daily (starting at 1 g/day on day 1 and titrated to achieve a goal of 2 g/day by week 2). The primary endpoint at week 52 was the percentage of participants who achieved sustained complete remission without experiencing treatment failure. Sustained complete remission was defined as achieving healing of lesions with no new active lesions (i.e., Pemphigus Disease Area Index activity score of 0) while on 0 mg/day prednisone or equivalent, and maintaining this response for at least 16 consecutive weeks, during the 52-week treatment period. Secondary endpoints were cumulative oral corticosteroid dose, number of disease flares, time to sustained complete remission, time to disease flare and health-related quality of life, as measured by the Dermatology Life Quality Index. 信息来源：Genetech |
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