From Clinical Oncology December 2011

Stockholm—Progression-free survival (PFS) in patients with metastatic non-small cell lung cancer (NSCLC) improved by almost 50% when pemetrexed was added to maintenance therapy with bevacizumab, according to an interim analysis of the AVAPERL trial.

At the recent European Multidisciplinary Cancer Congress, researchers reported that median PFS increased from 6.6 months in patients receiving bevacizumab (Avastin, Genentech) alone to 10.2 months when pemetrexed (Alimta, Eli Lilly) was added (abstract LBA34). When evaluated from the end of induction therapy, PFS was doubled with the combination compared with bevacizumab monotherapy.

“This is a benefit of unprecedented magnitude,” said Fabrice Barlesi, MD, a thoracic oncologist at the University of the Mediterranean in Marseille, France, who presented the data. “Overall survival [OS] data favor maintenance therapy with bevacizumab and pemetrexed, but the data are currently immature. The results strongly favor the use of bevacizumab plus pemetrexed as continuation maintenance therapy in patients with [biologically] nonselected metastatic non-small cell lung cancer.”

“A high proportion of non-small cell lung cancer (NSCLC) patients treated with erlotinib or gefitinib develop the gatekeeper EGFR T790M mutation. Identifying this mutation with our test will support development of promising next-generation EGFR-targeted therapies critical to overcoming resistance,” commented Stephane Wong, Chief Scientific Officer of MolecularMD.

The new U.S. Patent, No. 8,067,175, describes methods of detecting the EGFR T790M mutation as it relates to acquired resistance in patients harboring activating EGFR mutations. Monitoring for the emergence of the EGFR T790M mutation will allow for early identification of acquired resistance and prompt treatment intervention.

First Randomized Data Support Anti-Tumor Activity of Phosphatidylserine (PS)-Targeting Antibody Platform

TUSTIN, CA, Dec 06, 2011 (MARKETWIRE via COMTEX) — Peregrine Pharmaceuticals, Inc. PPHM +30.03% today announced preliminary results from a randomized Phase II trial showing a 50% improvement in overall tumor response rates (ORR) in non-small cell lung cancer (NSCLC) patients. Patients treated with bavituximab plus carboplatin and paclitaxel currently demonstrate an ORR of 39%, versus 26% in patients treated with carboplatin and paclitaxel alone. This preliminary analysis using RECIST guidelines included all 86 front-line, Stage IV NSCLC patients randomized in this Phase II trial.

Peregrine plans to report on secondary endpoints, including median progression-free survival (PFS) and overall survival (OS) once reached during 2012. Bavituximab’s therapeutic potential is being evaluated in three randomized Phase II trials in front-line NSCLC, second-line NSCLC, and front-line pancreatic cancer, as well as in four investigator-sponsored trials (ISTs) in additional oncology indications with clinical data from each study expected in 2012.

CAMBRIDGE, Mass., Nov. 18, 2011 /PRNewswire via COMTEX/ — Merrimack Pharmaceuticals, Inc. announced today that the first patient has been dosed in a Phase 2 clinical trial of MM-121, a fully human monoclonal antibody that targets ErbB3, in combination with erlotinib (Tarceva®), a small molecule directed at the epidermal growth factor receptor (EGFR), in three groups of patients with metastatic non-small cell lung cancer (NSCLC).

EAGAN, Minn., Nov 17, 2011 (BUSINESS WIRE) — Biothera’s Phase II non-small cell lung cancer (NSCLC) clinical trial evaluating Imprime PGG(R) administered in combination with cetuximab (Erbitux(R)), carboplatin and paclitaxel has met its goal of 90 patients and is fully enrolled, the company announced today.

The open label, multicenter, randomized trial was designed to evaluate the safety and efficacy of Imprime PGG in combination with a monoclonal antibody (cetuximab) and a standard chemotherapy regimen (carboplatin and paclitaxel) compared to cetuximab alone with the same chemotherapy.

“This is an important milestone in developing more effective treatments for NSCLC patients,” said Dan Conners, president of Biothera’s Pharmaceutical Group. “It is also a significant step forward in Biothera’s overall clinical development plan for Imprime PGG.”

The primary objective for the study is to determine the anti-tumor effects of Imprime PGG when used in combination with cetuximab and standard chemotherapy, based on overall response rate as assessed by RECIST (Response Evaluation Criteria in Solid Tumors) and evaluated by a blinded independent review committee.

 RIDGEFIELD, Conn., Nov. 16, 2011 /PRNewswire via COMTEX/ — Despite guidelines calling for genetic mutation testing in certain patients with lung cancer, three new surveys fielded by Harris Interactive reveal a disconnect in the understanding of and communication about genetic mutation testing among healthcare professionals and cancer patients. Results of the surveys were announced today by Boehringer Ingelheim Pharmaceuticals, Inc., which sponsored the surveys in partnership with the Association of Community Cancer Centers (ACCC), ONS:Edge and the National Lung Cancer Partnership (NLCP).

Surveys of 95 community oncologists, 522 oncology nurses and 436 lung cancer patients across the U.S. were collected in October 2011 to measure perceptions and knowledge of genetic mutation testing and to identify unmet needs and gaps in education.

Campaign Highlights Importance of Molecular Testing in Lung Cancer

NEW YORK, Nov 14, 2011 (BUSINESS WIRE) — –People with Lung Cancer Invited to Submit Their Personal Stories

Kathryn Joosten, two-time Emmy(R) Award-winning actress and star of Desperate Housewives and The West Wing, is opening up about her 10-year battle with lung cancer as part of a new national campaign, Lung Cancer Profiles. Lung Cancer Profiles aims to reduce the stigma associated with lung cancer by educating about the diversity of the disease inside and out. The campaign, created by Pfizer Oncology in collaboration with the nation’s leading lung cancer advocacy groups, also seeks to educate about the role of molecular testing and its potential to uncover the unique genetic drivers of each person’s cancer, which can help doctors devise an individualized treatment plan rather than using a one-size-fits all approach.

“I have lung cancer and it’s nothing to hide–anyone can get lung cancer, everyone’s cancer is different and it’s reassuring that the science is catching on,” Ms. Joosten said. “When my cancer returned after eight years, I was discouraged, but my doctor recommended I get my tumor tested to see if it would affect my treatment plan. We were able to identify my particular type of lung cancer and find a clinical trial designed specifically for people with my tumor type. I am passionate about this campaign because I know, first-hand, how hard it can be to learn you have lung cancer, how important it is to get tested and how impactful sharing my story might be on the lives of others with lung cancer.”

For the first time, investigators in the U.S. have demonstrated that it is possible to screen individuals with cancer for a variety of cancer-causing genetic mutations as part of normal clinical practice. Doctors have the ability to target tumors with the most suitable treatment by identifying patients’ individual genotypes within a fairly short time period.

The investigation was conducted in individuals with non-small-cell lung cancer (NSCLC), although investigators are already using it in a variety of other cancers as well. The study is published in the cancer journal, Annals of Oncology this week.

Individuals who suffer with NSCLC could have mutations in any of at least 14 different genes, although the number could be even higher. So far, it has only been possible to look for single or a small number of genetic mutations, but as several genes are found to be involved in more cancers, it is vital for researchers to develop methods to determine the mutational status of numerous genes at once.

Researchers Report Some Success Against Advanced Lung Cancer With Epigenetic Drugs

Nov. 9, 2011­ — A new approach to treating cancer appears to help certain patients with advanced lung cancer, and researchers say they think they may have a way of spotting those who will benefit.

The small study is generating big excitement in the world of cancer treatment because it demonstrates that so-called epigenetic drugs may work when traditional chemotherapy has failed.

Epigenetic drugs work by controlling gene expression — the way information from genes is used to create products such as proteins.

The study is published in Cancer Discovery.

“This is a … groundbreaking study, showing that by modifying the epigenetics of a cancer cell we can get real responses in lung cancer,” said Jeffrey A. Engleman, MD, PhD, director of thoracic oncology at Massachusetts General Hospital, in Boston, in a news briefing. “And getting real responses in lung cancer is actually quite difficult, so we take special notice of therapies that can do this.” He was not involved in the research.

Tübingen, Germany, November 7, 2011/ B3C newswire / – CureVac GmbH, the mRNA vaccine company, yesterday presented the results of a Phase I/IIa trial in non-small cell lung cancer (NSCLC) with CV9201, an mRNA-based cancer vaccine, in patients with NSCLC stage IIIB/IV after first-line chemo-radiotherapy or chemotherapy, respectively. The trial strived to assess safety and toxicity of CV9201 as well as its ability to induce antigen-specific humoral and cellular immune responses in cancer patients. The results suggest that CV9201 is safe, well tolerated and biologically active. The trial evaluated a five dose regime of CV9201 delivered via intradermal injection in 46 patients.

The trial with CV9201, conducted in Germany and Switzerland, was the first to test an immunotherapy based on CureVac´s RNActive® vaccination technology in patients after heavy pre-treatment with chemotherapy. 65% of the phase IIa study patients responded to at least one antigen out of the five antigens in CV9201. “Importantly, CureVac‘s therapeutic mRNA vaccine CV9201 induces responses against multiple antigens in two thirds of immunologically responding patients. Moreover, we see profound B-cell activation in 61% of the patients. This makes an overall antigen-specific or B-cell response of 84%. We also see immune responses against all included antigens. All in all, these data are extremely encouraging and confirm our previous results in prostate cancer,” said Dr. Kajo Kallen, CSO and CMO of CureVac.