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Genmab Announces European Regulatory Submission for Ofatumumab as Maintenance Therapy for Relapsed CLL

On July 7, 2015 Genmab reported that a variation to the Marketing Authorization has been submitted to the European Medicines Agency (EMA) for the use of ofatumumab (Arzerra) as maintenance therapy of patients with relapsed chronic lymphocytic leukemia (CLL) (Press release, Genmab, JUL 7, 2015, View Source [SID:1234506173]). The application was submitted by Novartis under our ofatumumab collaboration.

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The application is based on interim results from a Phase III study, PROLONG (OMB112517) which evaluated ofatumumab maintenance therapy versus no further treatment in patients with a complete or partial response after second or third line treatment for CLL. Results from this trial were presented at the 2014 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting.
"The PROLONG study showed the potential of using ofatumumab as an ongoing maintenance therapy for patients with relapsed CLL. We are pleased that Novartis has taken the next step with ofatumumab in this setting by submitting a regulatory application to the EMA," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.
About CLL
CLL, the most commonly diagnosed adult leukemia in Western countries, accounts for approximately 1 in 4 cases of leukemia1,2. Most CLL patients experience disease progression despite initial response to therapy and may require additional treatment3.
About Ofatumumab (Arzerra)
Ofatumumab is a human monoclonal antibody that is designed to target the CD20 molecule found on the surface of chronic lymphocytic leukemia (CLL) cells and normal B lymphocytes.
In the United States, Arzerra is approved for use in combination with chlorambucil for the treatment of previously untreated patients with CLL for whom fludarabine-based therapy is considered inappropriate. In the European Union, Arzerra is approved for use in combination with chlorambucil or bendamustine for the treatment of patients with CLL who have not received prior therapy and who are not eligible for fludarabine-based therapy. In more than 50 countries worldwide, Arzerra is also indicated as monotherapy for the treatment of patients with CLL who are refractory after prior treatment with fludarabine and alemtuzumab.
Arzerra is not approved anywhere in the world as maintenance therapy for relapsed chronic lymphocytic leukemia.
Please see full Prescribing Information, including Boxed WARNING for Arzerra (ofatumumab).
Arzerra is marketed under a co-development and collaboration agreement between Genmab and Novartis, as successor in interest to GSK.

Clearance of co-development and commercialization agreement with AstraZeneca and receipt by Innate Pharma of $250m initial payment

On July 7, 2015 Innate Pharma reported that the co-development and commercialization agreement with AstraZeneca on Innate Pharma’s proprietary anti-NKG2A antibody, IPH2201 (see announcement press release as of April, 24, 2015), received HSR clearance (Press release, Innate Pharma, JUL 6, 2015, View Source [SID:1234506176]). The companies will now begin to work together to accelerate and broaden the development of IPH2201, including in combination with MEDI4736, an anti-PD-L1 immune checkpoint inhibitor developed by MedImmune.

On June 30, 2015, Innate Pharma received the initial payment of $250 million from AstraZeneca.

Provectus Biopharmaceuticals’ Phase 1 PV-10 Data on Liver Cancer Presented at 6th Asia-Pacific Primary Liver Cancer Expert Meeting

On July 6, 2015 Provectus Biopharmaceuticals reported that data from its phase 1 study of PV-10 for chemoablation of hepatocellular carcinoma (HCC) and cancer metastatic to the liver was presented on July 3, 2015 at the 6th Asia-Pacific Primary Liver Cancer Expert Meeting (APPLE 2015) in Osaka, Japan (Press release, Provectus Pharmaceuticals, JUL 6, 2015, http://www.pvct.com/pressrelease.html?article=20150706.1 [SID:1234506169]).

The presenter was Dr. Sanjiv Agarwala, chief of medical oncology and hematology at St. Luke’s Cancer Center in Bethlehem, Pennsylvania, and professor of medicine at Temple University School of Medicine in Philadelphia, Pennsylvania. He serves as a principal investigator of the phase 1 clinical trial that produced the data presented, and is the lead investigator for the phase 3 clinical trial of PV-10 as an investigational treatment for melanoma which recently began. The poster presentation was titled "Phase 1 Study of PV-10 for Chemoablation of Hepatocellular Cancer and Cancer Metastatic to the Liver."

Based on the data presented, the researchers concluded that preliminary efficacy in treatment of liver tumors with PV-10, a 10% solution of rose Bengal, was observed with acceptable tolerability. The study is continuing at three study centers with two expansion cohorts to further assess safety and response in HCC and other cancers metastatic to the liver.

Provectus previously reported data on clinical and nonclinical testing of intralesional PV-10 as an investigational treatment for metastatic melanoma, where it has demonstrated high rates of complete response and durable local control in injected melanoma lesions. The phase 1 study reported at APPLE 2015 was designed to assess safety, pharmacokinetics and preliminary efficacy of PV-10 in subjects with non-resectable HCC or cancer metastatic to the liver.

In the phase 1 study, subjects having a target lesion in the liver at least 1 cm in diameter were administered a single percutaneous intralesional injection of PV-10 into their target lesion. Plasma concentrations of PV-10 from 1 hour to 28 days after injection were measured. Radiologic assessments of the injected target lesion were performed to determine response over an initial 28-day and longer term 9-15 month follow-up interval. Serum levels of potential liver injury markers were measured, and adverse events recorded.

In the initial study cohort, six subjects received PV-10 injections in two successive escalating dose cohorts of 0.25 and 0.50 mL per cm3 lesion volume. Significant adverse events were limited to injection site and photosensitivity reactions that resolved without sequelae. All injected tumors were stable in size at 28 days, and among four of the initial six tumors that had longer-term assessment, two had partial response.

The poster is now available online at: http://www.pvct.com/publications/APPLE-2015-PV-10-LC-01.pdf.

Celsion Announces Continuing Positive Data from Its Phase 2 DIGNITY Study in Breast Cancer

On July 6, 2015 Celsion reported positive interim data from its ongoing open-label Phase 2 DIGNITY Trial of ThermoDox in recurrent chest wall (RCW) breast cancer (Press release, Celsion, JUL 6, 2015, View Source [SID:1234506166]). The trial is designed to enroll up to 20 patients at several U.S. clinical sites and is evaluating ThermoDox in combination with mild hyperthermia. Of the 17 patients enrolled and treated, 13 were eligible for evaluation of efficacy. Based on data available to date, every patient experienced a clinical benefit of their highly refractory disease within the ThermoDox treatment field, with a local response rate of 69% observed in the 13 evaluable patients, notably five complete responses (CR), four partial responses (PR) and four patients with stable disease (SD). The Company will complete enrollment in the study in the third quarter of 2015.

"We have observed durable local responses in two-thirds of the patients treated using ThermoDox in three clinical trials to-date, which is significant considering the fact that these patients present with highly resistant chest wall tumors that had progressed on multiple previous therapies, including chemotherapy, radiation and hormone therapy," noted Dr. Nicholas Borys, Celsion’s senior vice president and chief medical officer. "We are aggressively pursuing opportunities to expand this program into Europe through the EURO-DIGNITY trial in which we expect to treat our first patient very soon."

These data are consistent with previously published Phase 1 data for ThermoDox plus hyperthermia in RCW breast cancer. The two similarly designed Phase 1 studies enrolled patients with highly resistant tumors found on the chest wall and who had progressed on previous therapies. Of the 29 patients treated in the two trials, 23 were eligible for evaluation of efficacy. A local response rate of 61% was reported in 14 of the 23 evaluable patients, with five complete responses and nine partial responses. A Clinical Response Rate (CR+PR+SD) was observed in 87% of the evaluable patients.

"These extremely impressive data position us to successfully pursue and take advantage of promising opportunities to accelerate the development and commercialization of ThermoDox in RCW breast cancer patients as we turn our attention to Europe and the initiation of EURO-DIGNITY, a multi-center study designed to evaluate ThermoDox’s potential to locally control chest wall lesions in earlier stage patients," stated Michael H. Tardugno, Celsion’s chairman, president and CEO. "Together, through our partnership with myTomorrows and our Early Access Program, our goal is faster commercialization and near-term revenue benefitting patients who are in dire need of more rapid access to new and better options for the treatment of this aggressive form of breast cancer."

The EURO-DIGNITY trial will evaluate ThermoDox plus hyperthermia and radiation in earlier stage breast cancer patients and is designed to support a registration filing in Europe. This study will be conducted in five countries with the support of key European investigators and with assistance from MedLogics Corporation, a hyperthermia device company based in Italy. In addition, Celsion has a license and distribution agreement with myTomorrows to implement an Early Access Program (EAP) for ThermoDox in all countries of the European Union plus Switzerland for the treatment of patients with RCW breast cancer. The Company expects to have ThermoDox available in mid-2015 for sale at commercial prices to physicians who are treating patients with limited therapeutic options. The EAP provides physicians with access to products in later stage development that demonstrate evidence of clinical benefit with an acceptable safety profile and a quality manufacturing process in place.

Phase III data published in The Lancet Oncology shows a significant overall survival benefit of Giotrif® (afatinib) compared to Tarceva® (erlotinib) in patients with previously treated advanced squamous cell carcinoma of the lung

On July 6, 2015 Boehringer Ingelheim reported The Lancet Oncology has published results from the LUX-Lung 8 trial (NCT01523587) (Press release, Boehringer Ingelheim, JUL 6, 2015, View Source [SID:1234506178]).

LUX-Lung 8 is the largest, prospective Phase III head-to-head trial directly comparing two EGFR-directed treatments. Afatinib* was tested versus erlotinib, an approved and recommended treatment in this setting according to international guidelines, in advanced squamous cell carcinoma (SCC) of the lung progressing after treatment with first-line platinum-based chemotherapy.1 Treatment options for SCC of the lung are limited and this type of lung cancer is associated with a poor prognosis, with less than 5% of patients with advanced SCC surviving for five years or longer.2,3

While afatinib is not yet approved for use in patients with SCC, the study showed that treatment with afatinib, an irreversible ErbB Family Blocker, resulted in superior progression-free survival (PFS, primary endpoint) and overall survival (OS, key secondary endpoint) compared to erlotinib in this patient population.1

Dr. Mehdi Shahidi, Medical Head, Solid Tumour Oncology, Boehringer Ingelheim commented: "The ErbB family of receptors plays an important role in the development of squamous cell carcinoma of the lung, and is a valid therapeutic target for this type of cancer. The broader and irreversible ErbB blockade of afatinib may explain the superiority shown in LUX-Lung 8 over erlotinib, an EGFR inhibitor already approved in this setting. We are pleased with the publication of LUX-Lung 8 data in The Lancet Oncology and based on the improvement in overall survival with the use of afatinib, we are in the process of preparing regulatory submissions."

Previously reported data demonstrated that the LUX-Lung 8 study met its primary endpoint as afatinib significantly improved PFS compared to erlotinib.1 In addition, afatinib extended OS of patients to a median of 7.9 months compared to 6.8 months on erlotinib, reducing the risk of death by 19%.1 In an updated PFS analysis, performed at the time of the OS analysis, patients treated with afatinib had a median PFS of 2.6 months compared to 1.9 months for erlotinib.4 More patients reported an improvement in overall well-being/quality of life with afatinib compared to erlotinib and the rate of severe adverse events was similar between the two treatment arms with differences observed in the incidence of certain adverse events.1 See the online publication for full details.