ESMO 2017 Press Release: LORELEI: Taselisib Boosts Breast Tumor Shrinkage

Excerpt:

“Adding taselisib to letrozole before surgery significantly improved outcomes for patients with early breast cancer that was both estrogen receptor positive and HER2-negative (ER+/HER2-) according to results of the LORELEI trial, presented at the ESMO 2017 Congress in Madrid.

” ‘We were able to detect a reduction in tumor size after only 16 weeks of treatment, compared to patients who received letrozole plus placebo,’ said study investigator Dr. Cristina Saura, from Vall d’Hebron University Hospital in Barcelona, Spain. ‘Any decrease in tumor measurements is something positive for patients because this means the drug has had activity against their tumor in a short period of time.’ ”

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#ESMO17 ROUNDUP: Merck’s Data on Keytruda/Chemo Combo for Lung Cancer Takes Early Spotlight at ESMO

Excerpt:

“Merck’s abstract $MRK on its big study of Keytruda (pembrolizumab) combined with chemo hit early at ESMO, attracting considerable attention for the impressive progression-free survival data the pharma giant posted as a frontline therapy for non-small cell lung cancer.

“The scoop: The median PFS hit 19 months for the combo arm compared to 8.9 months for chemo alone. The 18-month overall survival rate was 70% with pembro + chemo and 56% with chemo. That was an easy winner at the FDA and the new mark to beat in the hottest competition in drug development.”

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Update Confirms Benefit of Pembrolizumab Plus Indoximod in Melanoma

Excerpt:

“Adding the IDO inhibitor indoximod to pembrolizumab (Keytruda) led to an overall response rate (ORR) of 61% in patients with advanced melanoma, according to updated phase II data scheduled to be presented at the Third International Cancer Immunotherapy Conference in Frankfurt/Mainz, Germany.

“The updated data include a higher complete response (CR) rate of 20% compared with the 12% CR rate previously reported at the 2017 AACR Annual Meeting.1 The median progression-free survival (PFS) with the combination was 12.9 months, with a 1-year PFS rate of 56%.”

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Immunotherapy Combination Safe and 62 Percent Effective in Metastatic Melanoma Patients

Excerpt:

“Immunotherapy is a promising approach in the treatment of metastatic melanoma, an aggressive and deadly form of skin cancer; but for most patients, immunotherapy drugs so far have failed to live up to their promise and provide little or no benefit. In a phase 1b clinical trial with 21 patients, researchers tested the safety and efficacy of combining the immunotherapy drug pembrolizumab with an oncolytic virus called T-VEC. The results suggest that this combination treatment, which had a 62% response rate, may work better than using either therapy on its own. The study appears September 7 in the journal Cell.”

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Alectinib: ALEX and ALUR trials show CNS benefit in NSCLC

Excerpt:

“Data from two separate phase 3 studies to be presented at the ESMO 2017 Congress in Madrid, show alectinib’s particular central nervous system (CNS) activity in patients with advanced non-small cell lung cancer involving a mutation of the anaplastic lymphoma kinase gene (ALK-positive NSCLC).

Findings from the ALUR trial (1), as well as a secondary analysis of the ALEX trial (2) show alectinib can significantly decrease CNS progression of NSCLC, both in the first-line as well as the second-line treatment setting.

” ‘Patients with NSCLC have a high risk of CNS and brain metastases,’ commented Prof. Fiona Blackhall, from the University of Manchester and The Christie Hospital, UK.”

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Roche Presents Data From Global Phase III Study Showing Significant Clinical Benefit of Alecensa (Alectinib) in Later-Line Advanced ALK-Positive Lung Cancer

Excerpt:

“Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced results from the global phase III ALUR study showing that Alecensa® significantly reduced the risk of disease worsening or death (progression-free survival, PFS) by 85% compared to chemotherapy in patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC), who had progressed following treatment with platinum-based chemotherapy and crizotinib (hazard ratio [HR]=0.15, 95% CI: 0.08-0.29, p<0.001). Median PFS reported by the investigators, the primary endpoint of the study, was 9.6 months in patients who received Alecensa (95% CI: 6.9-12.2) compared with 1.4 months (95% CI: 1.3-1.6) in those who received chemotherapy. Median PFS assessed by an independent review committee (IRC), a secondary endpoint, was 7.1 months for patients who received Alecensa versus 1.6 months for patients who received chemotherapy (HR=0.32, 95% CI 0.17–0.59; p<0.001). The safety profile of Alecensa was consistent with that observed in previous studies and compared favourably to chemotherapy.”

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Pembrolizumab Shows Promise in Small Cell Lung Cancer

Excerpt:

“Pembrolizumab (Keytruda) induced an overall response rate (ORR) of 33% in patients with extensive-stage small cell lung cancer (SCLC), according to findings from the open-label, phase Ib KEYNOTE-028 trial published in the Journal of Clinical Oncology.

“One patient (4.2%) experienced a complete response, 7 (29.2%) had partial responses, and 1 (4.2%) had stable disease for less than 6 months. Thirteen patients (54.2%) experienced disease progression as the best overall response.”

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Z-Endoxifen Shows Promise as New Treatment for Common Breast Cancer Type

Excerpt:

“Z-endoxifen, a potent derivative of the drug tamoxifen, could itself be a new treatment for the most common form of breast cancer in women with metastatic disease. This finding was reported from a clinical trial conducted by researchers at Mayo Clinic and the National Cancer Institute, and published in the Journal of Clinical Oncology.

“The final results of a first-in-human phase I study of Z-endoxifen in women with estrogen receptor positive  showed that the treatment was safe and resulted in tumor shrinkage in women whose tumors had progressed on standard anti-estrogen therapies, including tamoxifen.”

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AKT Inhibitor Ipatasertib in Metastatic Triple-Negative Breast Cancer

Excerpt:

“The randomized phase II LOTUS trial has shown improved progression-free survival with the addition of the AKT inhibitor ipatasertib to paclitaxel in the first-line treatment of metastatic triple-negative breast cancer. These results were reported by Kim et al in The Lancet Oncology. The PI3K/AKT signaling pathway is frequently activated in triple-negative breast cancer.

“In the double-blind trial, 124 patients with unresectable locally advanced or metastatic disease from 44 sites in South Korea, the United States, France, Spain, Taiwan, Singapore, Italy, and Belgium were randomized between September 2014 and February 2016 to receive paclitaxel at 80 mg/m² on days 1, 8, and 15 with either ipatasertib at 400 mg (n = 62) or placebo (n = 62) once daily on days 1 to 21 every 28 days until disease progression or unacceptable toxicity. Stratification factors included tumor PTEN status as determined by immunohistochemistry; deficient expression of PTEN is associated with greater AKT pathway activation. The co-primary endpoints were progression-free survival in the intention-to-treat population and progression-free survival in the PTEN-low population.”

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