Roche, for its part, announcedthat the Phase III EMILIA study of trastuzumab emtansine (T-DM1) met itsco-primary endpoint, which was the significant improvement in the time patientswith HER2-positive metastatic breast cancer lived without their disease gettingworse, otherwise known as progression-free survival. The study showed that therisk of disease worsening or death was reduced by 35 percent for people whoreceived trastuzumab emtansine compared to those who received lapatinib plusXeloda (capecitabine) chemotherapy. A trend was also shown for patients whoreceived trastuzumab emtansine to live longer (overall survival, which was theother co-primary endpoint of the study) than those who received lapatinib plusXeloda—but Roche stresses that the overall survival data are not yet mature.
The safety profile of trastuzumab emtansine wasconsistent with that seen in previous studies, Roche notes, with fewer patientswho received trastuzumab emtansine experiencing Grade 3 or higher (severe)adverse events than those who received lapatinib plus Xeloda (40.8 percentcompared to 57 percent).
"The encouraging efficacy, safety profile andquality-of-life results from the EMILIA study support our belief thattrastuzumab emtansine may have an important role for patients withHER2-positive metastatic breast cancer," said Dr. Hal Barron, chief medicalofficer and head of global product development at Roche. "We are working withglobal regulatory authorities to submit these data as quickly as possible andhope that trastuzumab emtansine will soon be available to patients with thisaggressive type of breast cancer."
With two anti-cancer agents to show, GSK releasedfindings for its Phase III clinical study program evaluating single-agent therapy with the compounds dabrafenib andtrametinib in patients with BRAF V600 mutation-positive metastatic melanoma.
Both the BREAK3 study of dabrafenib (a BRAFinhibitor) and the METRIC study of trametinib (a MEK inhibitor) demonstrated astatistically significant benefit in progression-free survival or PFS) comparedto those receiving chemotherapy. Additionally, patients in the METRIC study whoreceived trametinib seem to demonstrate better overall survival than those whoreceived chemotherapy with dacarbazine; however, the overall survival data arenot yet mature in the BREAK3 trial.
"The results from the clinical studies ofdabrafenib and trametinib … represent important progress towards understandinghow these investigational agents could benefit patients with advanced andmetastatic melanoma. Importantly, trametinib is the first MEK inhibitor todemonstrate clinical benefit in a late phase melanoma trial." said Dr. RafaelAmado, head of oncology research and development for GSK. "We are planningregulatory submissions for dabrafenib and trametinib as single-agent therapiesand have recently started a Phase III program to further investigate the effectof the combination in this disease."
Finally, BMS has earlier-stage but still promisingdata, announcing interim results from the expanded Phase I dose-ranging study ofits investigational anti-PD-1 immunotherapy BMS-936558, which showed clinicalactivity in patients with previously-treated NSCLC, metastatic melanoma andrenal cell carcinoma.
As BMS explains, anti-PD-1 is a fully-humanantibody that targets the inhibitory receptor expressed on activated T-cellscalled PD-1, or programmed death-1. Objective response rates across dosecohorts, as measured by standard RECIST criteria, ranged from 6 percent to 32percent in NSCLC, 19 percent to 41 percent in metastatic melanoma and 24percent to 31 percent in renal cell carcinoma, with BMS reported that "mostresponses were durable."
"Immuno-oncology is a prioritized area of researchand development at Bristol-Myers Squibb and we plan to initiate registrationalstudies for anti-PD-1 in NSCLC and RCC this year and late 2012, early 2013 formetastatic melanoma," said Brian Daniels, senior vice president of globaldevelopment and medical affairs at BMS.
