Novartis Posts a Win, Roche a Flop in Skin Cancer Trials

Excerpt:

“Swiss drugmaker Novartis notched a trial win for its drug cocktail against skin cancer on Monday, while a rival treatment from Roche with slipping sales failed in a separate study with a similar patient group.

“All the medicines were tested in melanoma patients who had undergone surgery to cut out tumors and had a genetic mutation called BRAF, making them likely to respond to the targeted cancer pills. Patients with BRAF mutations constitute around half of the melanoma population.”

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ESMO 2017 Press Release: Patients with High Risk Prostate Cancer May Benefit “Equally” From Two New Treatments

Excerpt:

“Patients with high risk prostate cancer starting long-term hormone therapy may benefit from two new treatments, according to late-breaking results from the STAMPEDE trial presented at the ESMO 2017 Congress in Madrid.

“Long-term hormone therapy alone has been the standard of care for patients with high risk locally advanced or metastatic prostate cancer since the 1940s.”

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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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