Synta Announces Results from Final Analysis of the GALAXY-1 Trial of Ganetespib in NSCLC

“Synta Pharmaceuticals Corp. (NASDAQ: SNTA) today announced final results from the GALAXY-1 trial, a global, randomized, multi-center study designed to identify the patients with advanced non-small cell lung cancer (NSCLC) with adenocarcinoma histology most likely to benefit from second-line treatment with the Company’s lead drug candidate, the Hsp90 inhibitor ganetespib, in combination with docetaxel versus docetaxel alone. Ganetespib is a next-generation inhibitor of the chaperone protein Hsp90, which is critical for the activation and stability of numerous proteins that drive cancer growth and proliferation. Ganetespib has been studied in over 1000 patients to date.”

Editor’s note: This story is about clinical trials designed to test the effectiveness of a drug called ganetespib in people with non-small cell lung cancer (NSCLC). The drug manufacturer (Synta) recently reported updated results for one of the trials, GALAXY-1. The results confirm that the researchers were able to identify patients who were most likely to benefit from a treatment that combines ganetespib with the chemotherapy drug docetaxel.

Combination Therapies for Lung Cancer

“CANCER NETWORK: Dr. Jänne, epidermal growth factor receptor (EGFR) inhibitors are a mainstay of therapy for those advanced-stage lung cancer patients with tumors that harbor specific EGFR mutations. What have we learned in the last few years about which patients respond to which oral agents and antibodies against EGFR? “

Editor’s note: While not strictly “news,” this interview provides a good overview of currently available treatments for lung cancer.

Drug Combo May Knock Down Lung Cancer

“Some drug-resistant cancers of the lung, pancreas and breast might be made vulnerable again by treating them with a medication already approved for another type of cancer, according to a new study led by scientists at UC San Diego.

“Researchers at UCSD Moores Cancer Center said they plan to start a clinical trial to test the use of Velcade for lung cancer in about six months. This quick start is possible because the drug is currently on the market, said Dr. Hatim Husain, an author of the study who is designing the clinical trial. For more information about the trial, call (858) 822-5182.”

Editor’s note: Clinical trials can be important treatment options for some patients. This one might be particularly appropriate for people who have taken the drug Tarceva (erlotinib) but became resistant to it. The drug combination being tested in this clinical trial has previously shown disappointing results, but the researchers are hopeful that by using molecular testing to identify patients who are more likely to benefit, they may be able to successfully use the treatment. Learn more about clinical trials here.

Palbociclib Plus Letrozole Extended PFS in Metastatic Breast Cancer

“The addition of palbociclib to letrozole during first-line treatment significantly extended PFS in post-menopausal patients with ER-positive, HER-2–negative advanced breast cancer, according to final results of a randomized, open-label, phase 2 trial presented at the American Association for Cancer Research annual meeting.

“Palbociclib (PD-0332991, Pfizer), an inhibitor of cyclin-dependent kinases (CDK) 4 and 6, prevents DNA synthesis by blocking cell cycle progression. Results of preclinical studies showed HR-positive breast cancer cells are dependent on CDK-4/6 for growth, and a phase 1 study showed the combination of palbociclib and the antiestrogen drug letrozole appeared to be a safe, effective combination.”

Editor’s note: “PFS” stands for “progression-free survival.” It refers to a period of time in which a cancer patient does not experience worsening of his/her disease. In the clinical trial described here, a combination of two drugs —palbociclib and letrozole—extended PFS for some people with ER-positive, HER-2-negative advanced breast cancer.

Thematic Session 10: Update on treatment options for patients with CRPC

“There are new treatment options for castration resistant prostate cancer (CRPC) but finding the optimal strategy and selecting the right patient is still fraught with challenges and difficulties, according to uro-oncology experts during a thematic session at the 29th Annual EAU Congress in Stockholm, Sweden.

“ ‘With many prostate cancer patients hoping for a better life without symptoms of the disease, the aim is to identify which new drugs, or a combination of these drugs, can offer prolong survival or effectively palliate bone disease,’ said Prof. Maria De Santis who chaired Thematic Session 10.

“The session focussed on castration-resistant prostate cancer (CRPC) which is often considered one of the toughest challenges in uro-oncology since despite repeated treatments the disease accelerates or progresses with severe impact on quality of life (QoL).”

Editor’s note: This article is about an event at a urology conference in Sweden. During the event, participants discussed the latest in prostate cancer treatment, with a focus on castration-resistant prostate cancer (CRPC).

Phase II Trial of Efatutazone Shows Challenge of Matching Treatment to Population

“Work at the University of Colorado Cancer Center led to phase II trial of efatutazone with erlotinib in patients with refractory non-small cell lung cancer. Results are reported today at the American Association for Cancer Research (AACR) Annual Meeting 2014. While efatutazone did not improve the efficacy of erlotinib in this trial, researchers hope lessons from the trial will allow them to make better future use of the drug or other drugs in its class.

” ‘In oncology and especially in lung cancer, everything is personalized. We’re exploring different molecular markers that identify which drugs are for the right patient. After this phase II trial, we’re working to find the right biomarker that could help us discover who is most likely to respond to efatutazone. This trial was done in an unselected population. But if we had the right population with the right marker, we hope that we could find a meaningful effect,’ says Ana Oton, MD, investigator at the CU Cancer Center, Associate Professor of Medical Oncology at the University of Colorado School of Medicine, and the study’s first author.”

Editor’s note: This trial tested a treatment without the use of molecular testing to see which patients might have benefited. This is a problem in the design of many clinical trials, as our Chief Scientist explains here. For future testing of the treatment the scientists hope to identify a molecular test that will help them select patients who are more likely to benefit.

Nintedanib Combined With Docetaxel Is Effective Second-Line Option for Advanced NSCLC

“The combination of nintedanib and docetaxel ‘is an effective second-line option’ for patients with advanced non–small cell lung cancer (NSCLC) who have received previous treatment with one line of platinum-based therapy, according to results from the phase III LUME-Lung 1 study published in The Lancet Oncology. The combination improved progression-free survival for patients with refractory NSCLC irrespective of histology when compared to docetaxel (Taxotere) plus placebo, and ‘significantly prolonged overall survival of patients with adenocarcinoma, including patients with poor prognosis (ie, those who had progressed within 9 months of start of first-line therapy),’ Martin Reck, MD, Lung Clinic Grosshansdorf, Germany, and colleagues reported for the LUME-Lung 1 Study Group.”

Bayer Initiates Phase 3 Trial Of XofigoA® (radium Ra 223 Dichloride) Injection In Combination With Abiraterone Acetate For Asymptomatic Or Mildly Symptomatic Chemotherapy-Naive Patients With Bone P…

“Bayer HealthCare Pharmaceuticals Inc. today announced that the company has begun to enroll patients in a trial studying Xofigo ® (radium Ra 223 dichloride) injection in combination with abiraterone acetate and prednisone/prednisolone for the treatment of asymptomatic or mildly symptomatic chemotherapy-naive patients with bone predominant metastatic castration-resistant prostate cancer (mCRPC). The randomized, double-blind, placebo-controlled Phase 3 trial is designed to determine the effects of this combination treatment on symptomatic skeletal event-free survival.

” ‘Studies such as this one are important, as they help us understand the safety and efficacy of combining FDA-approved treatments for metastatic castration-resistant prostate cancer,’ said Pamela A. Cyrus, MD, Vice President and Head of U.S. Medical Affairs, Bayer HealthCare Pharmaceuticals.”

Editor’s note: Last year, Xofigo was approved by the U.S. Food and Drug Administration (FDA) for treating men with late-stage prostate cancer with bone metastases. (Read about the FDA-approval in a previous news story.) The new clinical trial described here will test whether treating patients with a combination of Xofigo and other drugs is safe and effective.

Innate Pharma SA begins Phase I Trial with Lirilumab and Nivolumab in Selected Solid Tumors Under Cohort Expansion

“Biopharmaceutical company Innate Pharma SA (euronext paris:FR0010331421) reported on Monday that it has started the cohort expansion portion of the Phase I clinical trial testing the combination of the two investigational checkpoint inhibitors lirilumab and nivolumab in selected solid tumors…

“The company said the trial will test lirilumab (anti-KIR checkpoint inhibitor; BMS-986015) in combination with nivolumab (anti-PD-1 checkpoint inhibitor BMS-936558) in solid tumors. The Phase I open label study will evaluate the safety of the combination of lirilumab and nivolumab and to provide preliminary information on the clinical activity of the combination. The primary outcome is safety.”

Editor’s note: Nivolumab is an immunotherapy drug that activates the immune system’s T cells in the hopes that the patient’s own immune system will be prompted to fight tumors. Nivolumab has already been shown to be a promising melanoma treatment on its own. Lirilumab is a drug that activates a different group of immune system cells known as natural killer cells (NK). This clinical trial combines both drugs to see if they work better together.