HPM15上关于重要药物的研发进展汇总

JP Morgan 2015 - Day 1

• Rociletinib for NSCLC; Rucaparib for Ovarian Cancer (CLVS). Clovis provided updated FDA filing timelines and development plans for rociletinib in non-small cell lung cancer and rucaparib in ovarian cancer. The company reiterated plans to file for FDA and EMA approval for rociletinib in T790M mutation-positive NSCLC patients in mid-2015, based on data from the TIGER-2 and TIGER-X (Phase II expansion) trials. Qiagen (QGEN) is working with Clovis to develop a companion diagnostic to test for T790M mutations. Furthermore, the company is now developing rociletinib in the larger population of T790M-negative patients, cohorts of whom are being added to the TIGER-2 and TIGER-3 trials. Patients without biopsied T790M mutations may benefit from rociletinib treatment due to tumor heterogeneity or due to the agent’s inhibition of IGF-1R, since the IGF pathway may play a pro-proliferative role in patients with acquired resistance to EGFR TKIs.
  
  Clovis重申基于TIGER-2和TIGER-X临床数据,其计划将于2015年中期向FDA和EMA提交CO-1686对T790M阳性的NSCLC的上市申请。另外，该公司正在将CO-1686的适应人群扩大至T790M阴性患者中，会将这部分患者增加到TIGER-2和TIGER-3临床试验中。对于组织样本不具有T790M突变的患者来说，可能会从CO-1686中收益，猜测是因为肿瘤异质性或者是1686对IGF-1R的抑制，因为对于对EGFR TKI耐药的患者来说，IGF通路扮演了提升细胞增殖能力的角色。
  
  In addition, the company now plans to file for FDA approval of rucaparib in ovarian cancer with a “BRCAness” signature in 2016, based on results from the expanded Phase II ARIEL2 trial. Clovis is working with Foundation Medical (FMI) to develop a companion diagnostic to test for BRCA and other DNA repair mutations.
  
• BMN 190 for Neuronal Ceroid Lipofuscinosis (BMRN). BMN 190 demonstrated stability versus matched natural history controls in a small Phase I/II study of CLN2, a late infantile form of Batten Disease. The company hopes to file on the data. While their chances depend on how comparable agencies believe the natural history data is, graphs showing consistency against a number of different matched controls were intriguing.
  VX-661 for Cystic Fibrosis (VRTX). Vertex released additional details about the VX-661 + ivacaftor Phase III program and announced it is to start in February. The program will include only one F508del homozygous study, but also additional heterozygous trials in patients with a gating mutation, residual function mutations, and minimal CFTR function. Phase IIb data from the double combination in F508del homozygous patients is expected to be released early this year, and officials additionally said a much anticipated trial with a next- generation corrector added to the double combination will also start this year.
  
• Keytruda for Non-Small Cell Lung Cancer (MRK). Merck added more pressure to the hotly-contested race to develop PD-1 immunotherapies by announcing plans to accelerate their timeline for Keytruda (lambrolizumab) in NSCLC. A BLA filing is now planned for mid-2015 which would put a potential approval much closer the anticipated approval for Opdivo near year end 2015.
  
• Imbruvica for Solid Tumors (PCYC). Imbruvica has been very successful in NHL, already gaining approval in both MCL and CLL. However, at the JPM session, the company suggested plans to evaluate the drug for solid tumors which would open up much larger markets for the pioneering BTK inhibitor.
  
• BART for Alzheimer’s Disease (BIIB). At the Deutsche Bank BioFEST conference last month, promising data were disclosed that the drug had shown a significant effect in cognition in a large Phase Ib study. However, the measures used to determine cognitive improvement were not detailed. At JPM, it was mentioned that the Clinical Dementia Rating Scale Sum of Boxes (CDR-SOB) and the Mini-mental state Examination (MMSE) were the specific endpoints.
  
  Biogen also announced that it is acquiring Convergence Pharmaceuticals with the acquisition centered on the development of CNV1014802 being developed for neuropathic pain. Positive data from a Phase II study in patients with trigeminal neuralgia (TGN) were presented in mid-2014, and a pivotal study is anticipated in early 2015.
  
• AG-120 for Hematologic Cancer (AGIO, CELG). Agios and Celgene announced that Celgene has exercised its option to license the isocitrate dehydrogenase (IDH) inhibitor AG-120 outside the U.S. The companies have been involved in a global strategic collaboration agreement, and Celgene exercised its licensing option for AG-221 (also an IDH inhibitor) last year. Both of these IDH inhibitors may alter cell metabolism to induce differentiation in cancer cells, thus reducing levels of aberrant proliferation.
  

JP Morgan 2015 - Day 2

• 4-Antigen Vaccine for Prevention of Staphylococcal Infections (PFE).Pfizer announced that the company plans to initiate a Phase IIb clinical trial for this vaccine candidate in patients receiving elective orthopedic surgery. This trial is potentially registrational (accelerated approval) and will initiate in mid-2015. In a Phase I/II study, healthy adults exhibited strong antibody responses following administration of a single, high-dose vaccine.
  
• PF-06463922 for NSCLC (PFE). Pfizer provided a fairly informative overview including the guidance that a pivotal NSCLC trial for their promising ALK-inhibitor, PF-06463922, is expected to start in 2015. Little information has been publicly released for this drug, but a fairly large Phase I/II study initiated nearly a year ago. The presentation also revealed broad plans to evaluate PFE’s immuno-oncology agents in combination with Merck KGaA’s PD-1 inhibitor, avelumab, after progress evaluating avelumab as a monotherapy has been made.
  
• REGN2810 for Cancer (REGN). Regeneron is joining the checkpoint inhibitor race with a the disclosure of an IND filing for its PD-1 inhibitor, REGN2810.
  
• Keytruda for Solid Tumors (MRK). Following its JPM presentation yesterday disclosing a more aggressive timeline for Keytruda (pembrolizumab) development in NSCLC, Merck and Eli Lilly announced a collaboration to conduct several trials evaluating Keytruda in combination with LLY’s compounds including pemetrexed, ramucirumab, and necitumumab.
  
• ZS-9 for Hyperkalemia (ZSPH). ZS Pharma continues to focus on its lead asset, ZS-9, which binds potassium to treat hyperkalemia. Positive pivotal trial data have already been presented, and regulatory filings are anticipated in the first half of 2015. The JPM presentation suggested pricing for ZS-9 could be in-line with other drugs used to treat electrolyte imbalances including Renvela ($750-800/mo.) and Sensipar. A tablet formulation, rather than the powder being used at launch, should be available approximately 1 year after initial approval.
  
• IMGN853 for Gynecologic Cancer (IMGN). Immunogen provided updates on the development timeline for IMGN853, an antibody-drug conjugate targeting folate receptor alpha (FR-alpha), at J.P. Morgan and in a press release immediately preceding the start of the conference. The sponsor expects to start Phase II trials in endometrial and/or ovarian cancer in 2015. Depending on the interim data and reception from regulatory agencies, these trials could be registrational (toward accelerated approval) given the unmet need in these gynecological cancers. Immunogen is partnering with Ventana/Roche to develop a companion diagnostic to quantitate FR-alpha expression on tumor biopsy samples.
  

真是好消息

不知4002耐药后换1686会不会有效。

在哪儿能搞到这个1686？

好消息，持续关注

持续关注1686

感谢分享，持续关注

好消息，感谢分享！持续关注