1stOncology™: Cancer Intelligence Service – Page 16754 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

TG Therapeutics, Inc. Announces Issuance of Composition of Matter Patent for TG-1101 in the United States

On April 13, 2016 (TG Therapeutics, Inc. (Nasdaq:TGTX) reported that the United States Patent and Trademark Office (USPTO) has issued a patent for the composition of matter of TG-1101, the Company’s novel, glycoengineered monoclonal antibody (Press release, TG Therapeutics, APR 13, 2016, View Source [SID:1234510746]). The patent, U.S. Patent No. 9,234,045 specifically covers the composition of TG-1101, and its use for treating various forms of CD20 expressing leukemia and lymphoma, including chronic lymphocytic leukemia (CLL) and various types of non-Hodgkin’s lymphoma, including follicular lymphoma (FL), marginal zone lymphoma (MZL), mantle cell lymphoma (MCL), and diffuse large B-cell lymphoma (DLBCL).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

Schedule Your 30 min Free Demo!

The patent was issued to LFB SA and is exclusively licensed to TG Therapeutics pursuant to the Company’s existing license agreement with LFB SA. The issuance affords patent protection for TG-1101 in the US through July of 2029, exclusive of additional patent term extensions also available. TG-1101 is currently being studied in two Phase 3 clinical trials in patients with CLL, with additional registration directed trials in NHL expected to commence in 2016.

"We are excited to announce the issuance of the first U.S. patent for TG-1101 which affords protection through 2029. With composition of matter patents now in place for both TG-1101 and TGR-1202, and an additional later-filed patent application on the combination of TG-1101 and TGR-1202, we believe we have established a very strong intellectual property position for the two components of our proprietary ‘TG-1303′ regimen that provides a very attractive exclusivity period without the risk of generic competition for many years to come," stated Michael S. Weiss, the Company’s Executive Chairman and Interim CEO. Mr. Weiss continued, "We remain focused on continuing to strengthen our intellectual property position through the issuance of additional patents for both TG-1101 and TGR-1202 individually as well as in combination here in the US and abroad."

Sarcoma Foundation of America Honors Advaxis for Advancements in Immunotherapy Platform

On April 13, 2016 Advaxis, Inc. (NASDAQ:ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, and the Sarcoma Foundation of America, reported that Advaxis has been awarded the 2016 Vision of Hope Award for their efforts to advance an immunotherapy platform to fight osteosarcoma in patients (Press release, Advaxis, APR 13, 2016, View Source [SID:1234510743]).

"The Sarcoma Foundation of America is proud to present the Vision of Hope Award to Advaxis Immunotherapies, a trailblazer in the osteosarcoma space," said Bert Thomas IV, Ph.D., Chief Executive Officer of the Sarcoma Foundation of America. "Their innovative technology gives hope to sarcoma patients in critical need of new treatments and paves the way for additional immunotherapies to offer patients a brighter future."

Advaxis is the first biotechnology company to ever receive the award for their work in the development of ADXS-HER2, an Lm Technology that has received an orphan drug designation from the FDA and EMA for treatment of osteosarcoma. In a study examining canine osteosarcoma, 18 dogs received either 2×108, 5×108, 1×109 or 3.3×109 CFU of ADXS–HER2 post-completion of surgery and adjuvant chemotherapy with 15 dogs showing an induced antigen-specific response within 6 months of immunotherapy administration. Additionally, treatment with ADXS-HER2 reduced the incidence of metastatic disease and prolonged survival relative to a historical control group with only low-grade, transient side-effects.

Osteosarcoma is the most common primary bone tumor in dogs, with more than 10,000 dogs annually diagnosed, and the most common bone cancer in children and teens. It is the third most common cancer in teens after lymphomas and brain tumors. HER2 is expressed in approximately 40 to 60 percent of pediatric and canine osteosarcomas and in pulmonary metastatic disease, providing a strong rationale for HER2 targeted immunotherapy in these cancers.

"We are honored to be chosen as a recipient of this prestigious Award from the Sarcoma Foundation of America," said Daniel J. O’Connor, President and Chief Executive Officer of Advaxis. "We recognize the serious unmet need to treat children and young adults battling this life-threatening disease and are proud to work towards developing immunotherapies that may help change the course of osteosarcoma patients’ lives."

Advaxis will receive the Vision of Hope Award at the Sarcoma Foundation of America 14th Annual Fundraising Event, "A Celebration of Life," on Thursday, May 12, 2016 at 6:00 PM EDT in New York City. For further information and to register, visit the Sarcoma Foundation of America’s website.

About Sarcoma

Sarcoma is a rare cancer in adults, accounting for 1 percent of all adult cancers, but rather prevalent in children, accounting for about 15 percent of all childhood cancers. At any one time, 50,000 patients and their families are struggling with sarcoma. Every year, nearly 15,000 new cases are diagnosed and about 6,000 people die from the disease.

About the Sarcoma Foundation of America

The Sarcoma Foundation of America (SFA), a 501(c)(3) nonprofit charitable organization, is an advocate for increased research to find new and better therapies with which to treat patients with sarcoma. The organization raises money to privately fund grants for sarcoma researchers and conducts education and advocacy efforts on behalf of sarcoma patients. For more information, please visit www.curesarcoma.org.

About ADXS-HER2

ADXS-HER2 is an Lm Technology immunotherapy product candidate being developed by Advaxis to target HER2 expressing cancers. ADXS-HER2 has received orphan drug designation by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of osteosarcoma. Advaxis is developing ADXS-HER2 for both human and animal health, and has seen encouraging data in canine osteosarcoma, which is considered a model for human osteosarcoma. Advaxis has licensed ADXS-HER2 to Aratana Therapeutics, Inc. for animal health therapeutics. Aratana expects to receive a conditional USDA license by the end of 2016 to market and sell ADXS-HER2 for dogs with canine osteosarcoma.

Boehringer’s Giotrif beats AZ’ Iressa in lung cancer trial

On April 13, 2016 Pharmatines reported that Boehringer Ingelheim’s Giotrif has beaten AstraZeneca’s Iressa on a number of clinical measures investigated in a head-to-head study involving patients with EGFR mutation-positive advanced non-small cell lung cancer (Press release, PharmaTimes, APR 13, 2016, View Source [SID:1234510736]).

The company says data from the Phase IIb LUX-Lung 7 trial, published in The Lancet, show that Giotrif (afatinib) significantly cut the risk of lung cancer progression and treatment failure, and boosted the overall response rate versus Iressa (gefitinib), "without compromising overall health-related quality of life, safety and tolerability".
Related Links
AZ’ Iressa bags US nod for first-line use
New EU lung cancer indication for Boehringer’s Giotrif

Giotrif reduced the risk of disease progression by 27 percent compared to Iressa, and, after two years’ treatment, more than twice as many patients taking the drug were alive and progression free than those taking AZ’ drug (27 percent vs 15 percent after 18 months, and 18 percent vs 8 percent after 24 months).

In addition, Giotrif-treated patients had a significantly longer time on treatment and risk of treatment failure was reduced by 27 percent, while significantly more patients had an objective tumour response compared to Iressa (70 percent vs 56 percent), with a median duration of response of 10.1 months and 8.4 months, respectively.

Both drugs showed similar improvements in patient-reported outcome measures with no significant differences in health-related quality of life. Treatment with both was generally tolerable, leading to an equal rate of treatment-related discontinuation in both arms (6 percent). The overall frequency of serious adverse events was 44.4 percent for Giotrif and 37.1 percent for Iressa.

"The totality of the efficacy data from LUX-Lung 7 clearly differentiates the second-generation inhibitor afatinib from the first-generation inhibitor gefitinib with no significant differences observed in overall safety, tolerability and health-related quality of life between the two TKIs," noted Professor Klaus Dugi, medical director and managing director, Boehringer Ingelheim UK & Ireland. "This is really good news for patients, and it will provide clinicians with further evidence to guide treatment practice in EGFR mutated NSCLC."

Data for the co-primary endpoint of overall survival are not yet mature and will be presented in the future, BI said.

Read more at: View Source#ixzz45iJQ5rGl
Follow us: @PharmaTimes on Twitter

Obesity fuelling leap in womb cancer cases

On April 13, 2016 PharmaTimes reported that Rising levels of obesity among UK women have helped drive a 54 percent jump in womb cancer rates over the last two decades, according to new figures released by Cancer Research UK (Press release, PharmaTimes, APR 13, 2016, View Source [SID:1234510735]).

Back in the early 1990s around 19 women in every 100,000 developed the disease, but that has now risen to 29 women in every 100,000, with obesity being the most likely driving force behind the increase, according to the charity.
Related Links
UK womb cancer rates highest in 30 years

In the UK around 9,000 women are now diagnosed with womb cancer every year, and around 2,000 die from the disease, a marked difference from the 4,800 annual new cases and 1,500 deaths recorded twenty years ago.

"It’s worrying that womb cancer cases are going up so sharply," said Professor Jonathan Ledermann, director of the Cancer Research UK and UCL Cancer Trials Centre. "We don’t know all the reasons why. But we do know that about a third of cases are linked to being overweight so it’s no surprise to see the increases in womb cancer cases echo rising obesity levels."

On the plus side, the figures also show that survival is improving. "In the 1970s, almost six in 10 women diagnosed with the disease survived for at least 10 years. Now almost eight in 10 women survive," said Prof Lederman. "But we need more research to understand the biology of the disease better and to know more about how it is caused so that we can improve the treatment of these women as well as preventing more cases."

Why extra weight can cause cancer is not entirely clear, but there is evidence to show that extra fat in the body can increase the risk by producing hormones and growth factors that promote cell division, the charity noted.

Head-to-head study demonstrating Giotrif® (afatinib) significantly improved clinical outcomes compared to Iressa® (gefitinib) in EGFR mutation-positive advanced non-small cell lung cancer published in The Lancet Oncology

On April 13, 2016 Boehringer Ingelheim reported that results from LUX-Lung 7, a global head-to-head Phase IIb trial comparing treatment with Giotrif (afatinib*) to Iressa (gefitinib) in patients whose tumours harbour the most common EGFR mutations were published in The Lancet Oncology (Press release, Boehringer Ingelheim, APR 13, 2016, View Source [SID:1234510770]).

LUX-Lung 7 lead investigator and lead author Professor Keunchil Park, Director of Innovative Cancer Medicine Institute (ICMI) at Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea commented: "The key finding from this study suggests a significant difference in efficacy between afatinib and gefitinib across multiple endpoints and pre-defined patient subgroups."

Results from the LUX-Lung 7 trial showed that afatinib significantly reduced the risk of lung cancer progression by 27% versus gefitinib.1 The improvement in progression-free survival (PFS) became more pronounced over time.1 After two years of treatment, more than twice as many patients on afatinib were alive and progression free than those on gefitinib (after 18 months; 27% vs 15% and after 24 months; 18% vs 8%).1

In addition, patients on afatinib had a significantly longer time on treatment, and risk of treatment failure was reduced by 27% versus gefitinib.1 Significantly more patients had an objective tumour response (ORR; a clinically meaningful decrease in tumour size) with afatinib when compared to gefitinib (70% vs 56%), with a median duration of response of 10.1 months and 8.4 months, respectively.1

Data for the co-primary endpoint of overall survival are not yet mature and will be presented in the future.

Both afatinib and gefitinib demonstrated similar improvements in patient-reported outcome measures in the LUX-Lung 7 trial with no significant differences in health-related quality of life with afatinib compared to gefitinib treatment.1 Treatment with both afatinib and gefitinib was generally tolerable, leading to an equal rate of treatment-related discontinuation in both arms (6%). Adverse events (AEs) observed in the trial were consistent with the known safety profiles of both treatments.1

The overall frequency of serious AEs was 44.4% for afatinib and 37.1% for gefitinib.2 The most common grade ≥3 related AEs with afatinib were: diarrhoea (13%) and rash/acne (9%), and with gefitinib: aspartate aminotransferase (AST)/alanine aminotransferase (ALT) increase (9%) and rash/acne (3%).1 Drug-related interstitial lung disease was reported for four patients on gefitinib and no patients on afatinib.1 Dose modification of afatinib was available in patients who met a set criteria in order to better manage AEs. As gefitinib is only available in one dose formulation, no dose reduction was administered.1

LUX-Lung 7 is the second head-to-head trial of afatinib versus a first-generation EGFR tyrosine kinase inhibitor (TKI). The first, LUX-Lung 8, compared afatinib to erlotinib in squamous cell carcinoma of the lung.

Mehdi_Shahidi
Dr. Mehdi Shahidi
"We are delighted with The Lancet Oncology publication of LUX-Lung 7, the second direct head-to-head trial of afatinib versus a first-generation EGFR TKI," said Mehdi Shahidi, M.D., Medical Head, Solid Tumour Oncology, Boehringer Ingelheim. "The totality of the efficacy data from LUX-Lung 7 clearly differentiates the second-generation inhibitor afatinib from the first-generation inhibitor gefitinib with no significant differences observed in overall safety, tolerability and health-related quality of life between the two TKIs. We expect the results to guide treatment practices in EGFR mutated NSCLC."

About the LUX-Lung 7 trial
LUX-Lung 7 is the first global, head-to-head trial comparing second- and first-generation EGFR-directed therapies (afatinib and gefitinib respectively) for patients with EGFR mutation-positive NSCLC who received no prior treatment. The Phase IIb trial included 319 patients with advanced stage NSCLC harbouring common EGFR mutations (del19 or L858R). The trial’s co-primary endpoints were PFS by independent review, time to treatment failure and overall survival (OS); and the secondary endpoints included ORR, disease control rate, tumour shrinkage, patient-reported outcomes and safety.

Results: compared to gefitinib, afatinib significantly improved1:

PFS (HR=0.73; 95% CI, 0.57‒0.95; p=0.017; median: 11.0 months [afatinib] versus 10.9 months [gefitinib]). The improvement in PFS with afatinib was consistent across pre-defined clinical subgroups, including gender, age, race and EGFR mutation type
Time to treatment failure (HR=0.73; 95% CI, 0.58‒0.92; p=0.0073; median: 13.7 months [afatinib] versus 11.5 months [gefitinib])
ORR (70% vs 56%, p=0.0083)
Afatinib is approved in over 60 countries for the first-line treatment of EGFR mutation-positive NSCLC*. Approval of afatinib in this indication was based on the primary endpoint of PFS from the LUX-Lung 3 clinical trial where afatinib significantly delayed tumour growth when compared to standard chemotherapy.3 In addition, afatinib is the first treatment to have shown an OS benefit for patients with specific types of EGFR mutation-positive NSCLC compared to chemotherapy.4 A significant OS benefit was demonstrated independently in the LUX-Lung 3 and 6 trials for patients with the most common EGFR mutation (exon 19 deletions; del19) compared to chemotherapy.4