Showing posts with label phase 3 trial. Show all posts
Showing posts with label phase 3 trial. Show all posts

Sunday, May 19, 2013

Antiangiogenic Agent Thalidomide No Good in Mesothelioma

Malignant pleural or peritoneal mesothelioma is invariably fatal cancer with options that are largely supportive in nature. The current first-line chemotherapy regimens including pemetrexed with or without cisplatin or carboplatin do not provide long-term survival. This cancer is highly angiogenic and thus preclinical and early data supported the use of anti-angiogenic agent thalidomide.

However, a recent clinical trial published in this month's issue of the journal Lancet Oncology shows that thalidomide when added to chemotherapy does not provide any additional benefit.  

Monday, June 4, 2012

Spotting EMILIA at ASCO12 Chicago


EMILIA trial is the first study to evaluate the efficacy of an antibody drug conjugate T-DM1 in metastaic breast cancer (mBC) patients.  At ASCO 2012 meeting in Chicago, Dr. Kim Blackwell of Duke University presented the final analysis of the progression-free survival (PFS) results in mBC patients treated with T-DM1.  A few days back, this trial was featured in the NBC Nightly News (read here.)

Sunday, June 3, 2012

Notes on Prostate Cancer From ASCO 2012

Phase 3 date on abiraterone trial in asymptomatic or mildly symptomatic patients with metastatic castration-resistant prostate cancer (mCRPC) was profiled in the ASCO daily news.  These results have the potential of changing the standard of care in mCRPC.

Saturday, March 31, 2012

EMILIA Study Results: Roche's Trastuzumab Emtansine (T-DM1) Delays Metastatic Breast Cancer Progression

Trastuzumab Emtansine (T-DM1) increases progression-free survival (PFS) in metastatic breast cancer patients compared to patients who received lapatinib (Tykerb; GlaxoSmithKline Plc) and  capecitabine (Xeloda; Roche) combination, Roche made the announcement today in a press release.  The overall surivival (OS) data is not mature yet.

Thursday, March 8, 2012

Zytiga is the Darling of the Day. Really!


Zytiga was in news today, but more so were its competitors, Provenge and MDV3100. The big news was early unblinding of Zytiga trial in metastatic prostate cancer patients due to significant improvement seen in progression-free survival (PFS) and other endpoints.

Thursday, December 8, 2011

Thursday, November 3, 2011

MDV1300 Making a Mark While Provenge Takes a Deep Plunge

Today San Francisco-based Medivation, Inc., ($MDVN) saw its stock value scale El Capitan within a day.  This coming on the heels of Dendreon Corp. ($DNDN) losing a huge chunk of its stock value yesterday is a good example of human psychology.  We reward "optimism" over "cautious behavior."  

Friday, February 25, 2011

HiJAKing the JAKs in Myeloproliferative Disorders


Myeloproliferative neoplasms (MPNs) are characterized by uncontrolled proliferation of differentiated myeloid cells in the bone marrow, and have an underlying clonal genetic change.  They often evolve into acute myelogenous leukemia (AML).  MPNs with chromosomal translocation t(9;22) BCR-ABL, also called Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML), have a very good prognosis.  Imatinib (Gleevec; Novartis) is a very effective inhibitor of BCR-ABL kinase.  On the other hand, Ph-negative MPNs, until recently had lacked targeted approaches.  This changed in 2005 with the discovery of a dominant gain-of-function somatic mutation in Janus Kinase-2 (JAK2) of a significant proportion of MPNs, wherein guanine-to-thymidine substitution results in a valine-to-phenylalanine change at position 617.  

Wednesday, November 17, 2010

CTing the risk of dying from lung cancer.

Is CT scan is to lung cancer what Pap smear is to cervical cancer?  Can routine CT-scan screening detect asymptomatic lung cancer and improve the odds of someone being a "lung cancer survivor."  The results of the NCI-sponsored National Lung Screen Trial (NLST) released recently, would like you to believe, yes, it is.

Tuesday, November 9, 2010

Watchlist: Will nimotuzumab emerge as one of the best-in-class anti-EGFR MAB?

 Nimotuzumab (h-R3mAb, TheraCIM) is an EGFR targeting monoclonal antibody approved for glioma, malignant astrocytomes and squamous cell carcinoma of head and neck in several countries outside US.  Phase II/III studies for FDA approval are ongoing.

Saturday, October 30, 2010

The Prostate Cancer: New drugs in the post “Abiraterone-Jevtana-Provenge” world


The success of three new drugs (Abiraterone, Jevtana and Provenge) for castration-resistant prostate cancer (CRPC) this year, each targeting different pathways, and all showing an overall survival benefit, has raised the bar for those dreaming to join the club.  There is at least one riding the popularity vote, MDV3100, which may complete phase 3 next year.  Still, many struggle and plough through phase  1 and 2.  One way to understand, what may make some of them unique – and the reason they may evolve into serious competition one day – is to lay them out in separate classes or targets.  This is what I have done below.

Tuesday, October 26, 2010

Cancer drugs RIPed in 2010


Four of the top ten Phase III failures of 2010 that were listed at FierceBiotech on Oct 21st are cancer drugs, and that's a big number!

Thursday, October 14, 2010

And the three co-winners in the 2010 race to beat Metastatic Advanced Prostate Cancer are Abiraterone, Jevtana and Provenge

Following the results of a randomized, placebo-controlled Phase 3 study COU-AA-301  released at the 35th Annual European Society for Medical Oncology (ESMO) Congress on October 11, 2010 (ESMO abstract LBA5), abiraterone has emerged as a third new treatment option for metastatic advanced prostate cancer (also referred to as hormone-refractory or castration-resistant prostate cancer [HRPC or CRPC]) this year.