On June 7, 2016 Theragenics Corporation, a medical device company serving the cancer treatment and surgical product markets, reported it has reached an agreement with Nihon Medi-Physics Co., Ltd. ("NMP") for the distribution and sale of Theragenics’ brachytherapy seeds in Japan (Press release, Theragenics, JUN 7, 2016, View Source [SID:1234513117]). In 2003, NMP sold the first I-125 seeds for the treatment of early stage prostate cancer in Japan after the procedure was approved there. Under the agreement, Theragenics will become NMP’s exclusive radioactive seed supplier for Japan, and NMP will be Theragenics’ exclusive distributor for the sale of radioactive seeds in Japan. Manufacturing and marketing authorization in Japan for Theragenics’ AgX100 I-125 product was received in March 2016. Shipment of the AgX100 products to Japan commenced on June 3, 2016.

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"Theragenics remains committed to prostate brachytherapy around the world," stated Frank J. Tarallo, Chief Executive Officer of Theragenics Corporation. "We are honored to partner with Nihon Medi-Physics, a leader in supporting prostate brachytherapy in Japan since the first implant there in 2003."

Mr. Tarallo continued, "Japan is an exciting market with the potential to grow. Theragenics has been a recognized leader in prostate brachytherapy with over 35 years’ experience in the manufacture and supply of seeds. Our brachytherapy products have been used to treat over 175,000 men and are now used to treat prostate cancer in 16 countries around the world. Our expertise, product quality and innovation combined with NMP’s knowledge of the market will create a dynamic partnership serving physicians and patients in Japan."

Hisashi Shimoda, President and Representative Director of Nihon Medi-Physics Co., Ltd. commented, "We are pleased by our new alliance with Theragenics Corporation, a major brachytherapy seed supplier. We believe that Theragenics’ brachytherapy products will enhance our capabilities to meet the needs of healthcare providers in Japan. With our new Theragenics alliance, NMP will be able to offer a more diversified mix of products and services, boosting our ability to improve the quality of life of as many prostate cancer patients as possible."

On June 7, 2016 Agendia, Inc., a world leader in personalized medicine and molecular cancer diagnostics, reported that it has presented new prospective data for its MammaPrint 70-gene breast cancer recurrence assay at the 2016 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, Illinois (Press release, Agendia, JUN 7, 2016, View Source [SID:1234513121]).

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Results from the Prospective study Of MammaPrint in breast cancer patients with an Intermediate recurrence Score (PROMIS) show that MammaPrint can provide clear guidance on whether a patient should receive chemotherapy, compared to the indeterminate results from 21-gene assay (OncotypeDx). MammaPrint provides a definitive, binary High or Low Risk result for a patient’s cancer recurring and thus whether the patient needs more aggressive, or less aggressive therapy.

Between 38-67% of women tested in different studies using the 21-gene assay were classified as having an intermediate/indeterminate Recurrence Score (between 18 and 30).1 PROMIS evaluated 840 estrogen receptor (ER)-positive, lymph node (LN) positive or LN negative women across 58 US institutions who had previously received an intermediate/indeterminate risk score from the 21-gene assay. Patient samples were re‑tested using MammaPrint to refine the risk classification and provide additional treatment guidance.

Of the 840 intermediate risk patients, MammaPrint reclassified 55% (466) of these patients as High Risk and 45% (374) as Low Risk of the individual’s cancer recurring. No correlation between definitive MammaPrint results or the indeterminate 21-gene assay Recurrence Score could be identified, reinforcing the discordance between these assays and inability to use the results interchangeably. MammaPrint was shown to provide additional prognostic information independent from clinicopathological factors to support the treatment decision.

Based on the outcome of the MammaPrint test, 34% (282/840) of physicians changed their treatment decisions, preventing both under and over treatment: 37% (171/466) of the high risk patients had chemotherapy added to their treatment recommendation and 29% (108/374) of the low risk patients had chemotherapy removed from their treatment recommendation. Of the MammaPrint Low Risk patients who were previously indicated to receive chemotherapy based on the 21-gene assay results, 76% of patients (108/142) decided to forego chemotherapy, preventing unnecessary overtreatment in this group.

Medical oncologist Dr. Michaela Tsai from the Virginia Piper Cancer Center, Minneapolis, MN and primary author of the PROMIS poster commented, "Of 466 intermediate patients reclassified as High Risk by MammaPrint, 342 have an Recurrence Score ≤25 and were not recommended for chemotherapy by St. Gallen Guidelines (Goldhirsch, Winer et al. 2013), risking up to a 73% chance of under-treatment." She also noted, "79% of physicians reported that they had greater confidence in their treatment recommendations with MammaPrint."

Dr. William Audeh, Chief Medical Officer of Agendia said: "The clinical performance of MammaPrint and its ability to accurately inform and guide treatment decisions has been definitively proven by the recent presentation of the MINDACT trial at the 2016 AACR (Free AACR Whitepaper) meeting. This unique phase III prospective, randomized, controlled study provides the highest level of clinical evidence to MammaPrint above any other genomic assay for making adjuvant therapy decisions in early-stage breast cancer."

MINDACT included 6,693 patients and is a phase III, prospective, randomized controlled, clinical trial comparing the use of MammaPrint 70-gene assay with clinicopathological criteria (current standard of care) for selecting early-stage breast cancer patients who should be treated with adjuvant chemotherapy.

"The PROMIS trial showed the positive impact a binary test could have in the clinical setting by providing a clear risk assessment of the patient to physicians" said Mark Straley, Chief Executive Officer at Agendia. "MammaPrint is the only FDA-cleared assay for early-stage breast cancer patients of all ages, further validating the quality and clinical utility of the test."

1 Lo, Mumby et al. 2011, Sulayman, Spellman et al. 2012, Stemmer, Klang et al. 2013, Sparano, Grey et al. 2015

On June 7, 2016 Transgenomic, Inc. (TBIO), (NASDAQ: TBIO), reported that it is unveiling new data at the American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2016 Annual Meeting further confirming the utility, speed and efficiency of its ICE COLD-PCR (ICP) technology for liquid biopsy detection of tumor mutations (Press release, Transgenomic, JUN 7, 2016, View Source [SID:1234513122]). The company is distributing a new educational handout at the meeting highlighting expanded concordance data showing that ICP plasma-based liquid biopsies detect all of the mutations identified using conventional tissue samples and also detect additional tumor alterations missed by conventional methods. Another educational handout presents data showing how use of ICP with Thermo Fisher’s Veriti thermal cycler expedites the testing of liquid biopsy samples, producing accurate results rapidly and efficiently.

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TBIO President and CEO Paul Kinnon commented, "As the highest profile cancer meeting of the year, ASCO (Free ASCO Whitepaper) is an excellent venue for presenting our expanded concordance study data further confirming the accuracy and superior performance of ICE COLD-PCR liquid biopsies for tumor detection and monitoring. We also are unveiling new study data highlighting the speed and efficiency of our ICP enrichment technology when used with a leading thermal cycler. We believe ICP’s accuracy, versatility and ease of use have the potential to enable wide adoption of routine genomic testing in cancer research and patient care, and the new data we are discussing at ASCO (Free ASCO Whitepaper) further supports the technology’s near-term clinical and commercial potential."

At the ASCO (Free ASCO Whitepaper) meeting, Transgenomic is distributing an educational report, "CRC Concordance Update – Stage IV CRC Sample Analysis with ICE COLD-PCRTM," which describes the results of an expanded concordance study assessing the ability of its multiplexed ICE COLD-PCR technology to detect a key tumor mutation in matched plasma samples compared to detection in the same patients using tissue and plasma samples analyzed using conventional Sanger sequencing methods. The expanded study included 32 patients with late stage colorectal cancer. Use of ICP-enriched testing resulted in an overall 96.9% concordance rate, with a 94.7% concordance rate for the mutation positive samples. In addition, actionable mutations were detected in two patient samples analyzed using ICP-enriched methods that were missed using conventional PCR with Sanger sequencing. Notably, the missed mutations were detected by ICP in both the plasma and tissue samples from these patients.

The researchers conclude that the high concordance rates achieved in the study and the ability of the ICP-enriched approach to detect relevant mutations missed by conventional methods support the clinical validity and utility of ICP-based liquid and tissue biopsies for mutation detection and monitoring in cancer patients.

Anil Vachani, MD, MS, Associate Professor of Medicine at the Hospital of the University of Pennsylvania and the Veteran’s Administration Medical Center and an investigator working with TBIO, commented, "The ability to accurately and efficiently detect tumor mutations from non-invasive blood-based patient samples is essential for realizing the potential of precision medicine approaches to transform cancer treatment. I welcome studies that increase our confidence in the validity of new technologies such as ICE COLD-PCR to help enable use of targeted and other precision treatment approaches."

A second TBIO educational handout, "Simple and Effective Clinical Testing Protocol Using ICE COLD-PCRTM across Targeted Cancer Gene Panels using the Veriti Thermal Cycler and Sanger Sequencing," details a new study that demonstrates how combining multiplexed ICE COLD-PCR with the Thermo Fisher Veriti thermal cycler expedites mutation detection and monitoring using liquid biopsy samples. It shows that with the Veriti thermal cycler, ICE COLD-PCR amplifications can be grouped based on temperature and primer annealing parameters to enable multiple amplicon enrichments in a single thermal cycler run. By combining the flexibility of the Veriti thermal cycler, the superior enrichment power of ICP and the rapid turnaround time of Sanger sequencing, liquid biopsy test results were generated in about four days, compared to total turnaround times of about four weeks for conventional tissue biopsies. Rapid results are an important advantage in cancer clinical testing and patient monitoring, where critical patient treatment decisions increasingly rely on up-to-date genomic data.

The study researchers note too that these results provide an opportunity for molecular diagnostic laboratories to reevaluate the use of Sanger sequencing for confirmation of mutation detection results from next-generation sequencing (NGS) platforms, and point out that by using this protocol, Sanger platforms can also be re-considered for front line mutation detection, with the potential to produce accurate results more rapidly and cost effectively than NGS platforms.

ICE COLD-PCR achieves its ultra-high sensitivity through selective amplification of mutant DNA. The result is up to a 500-fold increase in sensitivity in identifying mutations with the most precise sequence alteration detection rates available. ICP was originally developed by the laboratory of Dr. Mike Makrigiorgos at the Dana-Farber Cancer Institute, which has exclusively licensed rights to the technology to Transgenomic.

On June 06, 2016 Advaxis, Inc. (NASDAQ:ADXS), a clinical stage biotechnology company developing cancer immunotherapies, reported that the Gynecologic Oncology Group (GOG), now part of NRG Oncology (NRG) will present additional preliminary data from a two-stage Phase 2 study of its lead immunotherapy candidate, axalimogene filolisbac (AXAL), in patients with persistent or recurrent metastatic (squamous or non-squamous cell) carcinoma of the cervix (PRmCC) who have progressed on at least one prior line of systemic therapy (Press release, Advaxis, JUN 6, 2016, View Source [SID:1234513031]).

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These data will be featured at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, Ill., in the Gynecologic Cancer General Poster Session on June 6 at 1:00 PM CT and also in an Oral Poster Discussion Session at 4:45 PM. The poster (abstract #5516), "ADXS11-001 immunotherapy in squamous or non-squamous persistent/recurrent metastatic cervical cancer: Results from stage 1 [and stage 2] of the phase II GOG/NRG-0265 study" and presentation are available at www.advaxis.com. Warner K. Huh, M.D., Professor and Division Director of Gynecologic Oncology and Senior Scientist at the University of Alabama at Birmingham, is the lead author and principal investigator.

GOG/NRG-0265 is a single-arm two-stage, Phase 2 multicenter study (NCT01266460). Stage 1 of the trial enrolled 26 AXAL-treated patients who received up to three doses at 1×109 colony forming units administered in 28 day intervals. Results from Stage 1 demonstrated a twelve-month survival rate of 38.5 percent, which exceeds prior historical GOG trials in this patient population. The twelve-month survival rate among the 69 percent of patients who received the maximum three per protocol doses was 56 percent, with a 12.1-month median overall survival. Safety and efficacy results of Stage 1 met the criteria for the initiation of Stage 2, which was amended for continuous cycles of AXAL (greater than three doses).

Twenty-four patients were treated with AXAL in Stage 2. However, a temporary clinical hold limited overall exposure to the immunotherapy, which necessitated 10 patients who had not progressed to discontinue AXAL treatment. Further, only 12 of the 24 patients received three or more doses. Demographics in the truncated Stage 2 cohort were similar to Stage 1, but a substantially higher proportion of patients were pre-treated with bevacizumab (83 percent (Stage 2) vs. 31 percent (Stage 1)).

At a median follow-up of 8.7 months, these Stage 2 results demonstrate a 42 percent six-month overall survival rate, which increases to 67 percent in those 12 patients who received three or more doses of AXAL. Preliminary results from Stage 2 appear consistent with the promising survival results from Stage 1 in a more heavily bevacizumab pre-treated population.

Investigator assessment of tumor best response showed disease control rates (CR+PR+SD) of 27 percent and 37 percent in Stage 1 and 2, respectively. Of particular note, a patient in Stage 2 experienced a complete response following three doses of AXAL. This patient continues to be followed with no evidence of disease at 11 months. Treatment with AXAL will resume under a compassionate use single-patient IND.

The safety profile across both stages was similar, with primarily grade one and two treatment-related events such as fatigue, chills, fever, nausea. Grade three events (n = 4 in Stage 1) included hypotension and cytokine release syndrome. No grade four or five treatment-related adverse events were observed.

Given the substantial proportion of Stage 2 patients that discontinued treatment with AXAL as a result of the clinical hold, Advaxis and the GOG/NRG agreed to re-enroll a new cohort of Stage 2 patients. The re-enrollment of Stage 2 is expected to commence shortly.

"We are excited about the potential of AXAL to help women with recurrent cervical cancer as there are so few options available," said Daniel J. O’Connor, President and Chief Executive Officer of Advaxis.

The Company and the GOG Foundation plan to commence enrollment to an international Phase 3 adjuvant study, AIM2CERV, for patients with high risk, locally advanced cervical cancer.

About Cervical Cancer

Cervical cancer is the fourth most common cancer in women worldwide. In the U.S., nearly 13,000 new cases are diagnosed, and approximately 4,100 deaths are reported because of cervical cancer. According to the WHO/ICO Information Centre on HPV and Cervical Cancer, about 3.9 percent of women in the U.S. are estimated to harbor high-risk cervical HPV infection at a given time, and 71.7 percent of invasive cervical cancers are attributed to high-risk HPV strains.

About the Gynecologic Oncology Group

The Gynecologic Oncology Group (GOG), now part of NRG Oncology, is a non-profit international organization with the purpose of promoting excellence in the quality and integrity of clinical and basic scientific research in the field of gynecologic malignancies. The GOG is committed to maintaining the highest standards in clinical trials development, execution, analysis and distribution of results. Continuous evaluation of its processes is utilized in order to constantly improve the quality of patient care. The GOG conducts clinical trials for patients with a variety of gynecologic malignancies, including cancers that arise from the ovaries, uterus, cervix, vagina and vulva. General information on many of these trials for medical professionals and the lay public can be obtained from ClinicalTrials.gov.

NRG Oncology is one of four adult cooperative groups funded under the newly structured NCI National Clinical Trials Network. NRG Oncology is comprised of three legacy cooperative groups, the National Surgical Adjuvant Breast and Bowel Project (NSABP), the Radiation Therapy Oncology Group (RTOG), and the Gynecologic Oncology Group (GOG).

About Axalimogene Filolisbac

Axalimogene filolisbac (AXAL) is Advaxis’ lead Lm Technology immunotherapy candidate for the treatment of HPV-associated cancers and is in clinical trials for three potential indications: invasive cervical cancer, head and neck cancer, and anal cancer. In a completed randomized Phase 2 study in recurrent/refractory cervical cancer, AXAL showed apparent prolonged survival, objective tumor responses, and a manageable safety profile alone or in combination with chemotherapy, supporting further development of the Company’s Lm Technology. AXAL has Orphan Drug Designations in the U.S. for the treatment of invasive cervical cancer, head and neck cancer and anal cancer.

On June 6, 2016 Seattle Genetics, Inc. (NASDAQ:SGEN) and Astellas Pharma Inc. (TOKYO:4503) reported first clinical data for ASG-15ME and enfortumab vedotin (ASG-22ME) at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 51st Annual Meeting being held June 3-7, 2016, in Chicago, IL (Press release, Seattle Genetics, JUN 6, 2016, View Source;p=RssLanding&cat=news&id=2175252 [SID:1234513055]).

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ASG-15ME and enfortumab vedotin are investigational antibody-drug conjugates (ADCs) that consist of monoclonal antibodies designed to deliver microtubule-disrupting agents selectively to tumor cells. This approach is intended to spare non-targeted cells and thus reduce many of the toxic effects of traditional chemotherapy while enhancing antitumor activity. ASG-15ME and enfortumab vedotin target SLITRK6 and Nectin-4, respectively, proteins that are highly expressed in urothelial cancers, particularly bladder cancer. Under the collaboration, the companies are co-developing and plan to globally co-commercialize ASG-15ME and ASG-22ME.

"Bladder cancer is the fifth most common cancer in the U.S., and there have been few treatment advances over the past three decades. For metastatic disease, the five-year survival rate is only 15 percent, representing a significant unmet need to identify additional treatment options," said Len Reyno, M.D., senior vice president and chief medical officer, Agensys, an affiliate of Astellas. "We are pleased to present these first data for ASG-15ME and ASG-22ME in urothelial cancers, which have a particularly high unmet medical need."

"The clinical data from the phase I presented at ASCO (Free ASCO Whitepaper) from the ASG-15ME and enfortumab vedotin programs in heavily pretreated metastatic bladder cancer patients show a manageable safety profile along with objective response rates that are higher than historical rates seen with taxanes," said Jonathan Drachman, M.D., chief medical officer and executive vice president, Research and Development at Seattle Genetics. "We will continue enrolling patients in the ongoing phase I clinical trials to determine the recommended dose for further development."

The following data were presented during poster sessions on Monday, June 6, 2016:

Anti-Tumor Activity, Safety and Pharmacokinetics (PK) of AGS15E (ASG-15ME) in a Phase I Dose Escalation Trial in Patients (Pts) with Metastatic Urothelial Cancer (mUC) (Abstract #4532, poster presentation on Monday, June 6, 2016)
Data were reported from 49 patients with metastatic urothelial cancer. The median age of patients was 64 years. Of the 49 patients, 48 patients (98 percent) had undergone treatment with a platinum-based chemotherapy regimen, including 33 patients (67 percent) with a cisplatin-based regimen, and 14 patients (29 percent) who had progressed on or after treatment with checkpoint inhibitors. Twenty-nine patients (59 percent) had received two or more prior systemic therapies. The primary endpoints of the ongoing clinical trial are to evaluate escalating doses, pharmacokinetics and safety of ASG-15ME as a monotherapy. In addition, the trial is evaluating antitumor activity, objective response rate and disease control rate. In this dose-escalation study, patients received ASG-15ME at 0.1 to 1.25 milligrams per kilogram (mg/kg) weekly for three of every four week cycles. Key findings include:
Of the 43 patients evaluable for response, 14 patients (33 percent) had an objective response, including one patient (two percent) who achieved a complete response and 13 patients (30 percent) who achieved a partial response. While the study is ongoing, preliminary estimates show median duration of response at 16.1 weeks. Disease control was achieved for 27 patients (63 percent), defined as achieving complete remission, partial remission or stable disease.
In 16 patients treated at the 1.0 mg/kg dose level, seven patients (44 percent) had an objective response. In five patients treated at the 1.25 mg/kg dose level, two patients (40 percent) had an objective response.
In the 13 patients whose cancer had metastasized to the liver, four patients (31 percent) achieved a partial remission. Bladder cancer that metastasizes to the liver typically has a poor prognosis.
In the 14 patients who had previously been treated with checkpoint inhibitors, five patients (36 percent) achieved a partial remission.
The most common treatment-related adverse events of any grade occurring in 15 percent or more of patients were fatigue (43 percent) and nausea (20 percent). Peripheral neuropathy was observed in 10 patients (19 percent) at Grade 1 and six patients (11 percent) at Grade 2. No Grade 3 or 4 peripheral neuropathy was reported.
In the study, eight patients developed ocular symptoms with corneal abnormalities. The majority of patients were managed with dose reductions and recovered.
Enrollment is ongoing at 1.0 and 1.25 mg/kg to identify a recommended dose for future studies.
Anti-Tumor Activity, Safety and Pharmacokinetics (PK) of ASG-22CE (ASG-22ME; enfortumab vedotin) in a Phase I Dose Escalation Trial in Patients (Pts) with Metastatic Urothelial Cancer (mUC) (Abstract #4533, poster presentation on Monday, June 6, 2016)
Data were reported from 44 patients with metastatic urothelial cancer. The median age of patients was 66.5 years. Of the 44 patients, 43 patients (98 percent) had undergone treatment with a platinum-based chemotherapy regimen, including 30 patients (68 percent) with a cisplatin-based regimen, and 12 patients (27 percent) who had progressed on or after treatment with checkpoint inhibitors. Twenty-eight patients (64 percent) had received two or more prior systemic therapies.
The primary endpoints of the ongoing clinical trial are to evaluate escalating doses, pharmacokinetics and safety of enfortumab vedotin as a monotherapy. In addition, the trial is evaluating antitumor activity, objective response rate and disease control rate. In this dose-escalation study, patients received enfortumab vedotin at 0.5 to 1.25 mg/kg weekly for three of every four week cycles. Key findings include:
Of the 36 patients evaluable for response, 10 patients (28 percent) achieved a partial response. While the study is ongoing, preliminary estimates show median duration of response at 16.1 weeks. Disease control was achieved for 25 patients (69 percent), defined as achieving complete remission, partial remission or stable disease.
In eight patients treated at the 1.25 mg/kg dose level, four patients (50 percent) had an objective response.
In the 10 patients whose cancer had metastasized to the liver, four patients (40 percent) achieved a partial remission. Bladder cancer that metastasizes to the liver typically has a poor prognosis.
In the 12 patients who had previously been treated with checkpoint inhibitors, three patients (25 percent) achieved a partial remission.
The most common treatment-related adverse events of any grade occurring in 15 percent or more of patients were pruritis and nausea (30 percent each), fatigue (25 percent), diarrhea (21 percent) and rash (18 percent). Peripheral neuropathy was observed in 11 patients (19 percent) at Grade 1 and three patients (five percent) at Grade 2. No Grade 3 or 4 peripheral neuropathy was reported.
In the study, two patients developed ocular symptoms with corneal abnormalities. The patients were managed with dose reductions and/or steroid eye drops.
Enrollment is ongoing at 1.0 and 1.25 mg/kg to identify a recommended dose for future studies.
The ASG-15ME and enfortumab vedotin phase I clinical trials are ongoing to identify a recommended dose for future clinical evaluation. More information about the clinical trials, including enrolling centers, is available by visiting www.clinicaltrials.gov.

About Bladder Cancer

Bladder cancer begins when cells in the urinary bladder start to grow uncontrollably. Most bladder cancers start in the innermost lining of the bladder, which is called the urothelium or transitional epithelium. Urothelial carcinoma, also known as transitional cell carcinoma (TCC), is the most common type of bladder cancer. Urothelial carcinoma starts in the urothelial cells that line the inside of the bladder.

While patients with early stage bladder cancer are treated with curative intent, outcomes are poor for patients diagnosed with locally advanced or metastatic disease. For the approximately 10 percent of patients with urothelial bladder cancer whose initial diagnoses occur when they have metastatic disease, the average five-year survival is approximately 15 percent. According to the American Cancer Society, in 2016 approximately 77,000 people will be diagnosed and more than 16,000 will die from urothelial bladder cancer.

About ASG-15ME and Enfortumab Vedotin

ASG-15ME is an investigational antibody-drug conjugate (ADC) composed of an anti-SLITRK6 monoclonal antibody attached to a microtubule-disrupting agent, monomethyl auristatin E (MMAE), using Seattle Genetics proprietary, industry-leading linker technology. ASG-15ME is the first and only agent to target SLITRK6, a transmembrane protein identified as an ADC target by Agensys, which is expressed on many solid tumors. Preclinical data demonstrate that ASG-15ME effectively binds to target cells, internalizes and induces cell-killing activity.

Enfortumab vedotin is an investigational ADC composed of an anti-Nectin-4 monoclonal antibody attached to a microtubule-disrupting agent, MMAE, using Seattle Genetics’ proprietary, industry-leading linker technology. Enfortumab vedotin is the first and only agent to target Nectin-4, a cell adhesion molecule identified as an ADC target by Agensys, which is expressed on many solid tumors. Preclinical data demonstrate that enfortumab vedotin effectively binds to target cells, internalizes and induces cell-killing activity.