Tuesday, May 10, 2022

FDA Grants Fast Track Designation to VB-111 for Platinum-Resistant Ovarian Cancer

This is excerpted from an article in OncLive by Chris Ryan April 22, 2022
The FDA has granted a fast track designation to VB-111 (ofranergene obadenovec), a targeted anticancer viral gene therapy, for use as a potential therapeutic option in patients with platinum-resistant ovarian cancer.
    VB-111 is designed to use a dual mechanism to target a wide range of solid tumors, including ovarian cancer. The mechanism pairs the blockade of tumor vasculature with an antitumor immune response. Prior data from a phase 1/2 trial (NCT01711970) indicated that when VB-111 was combined with paclitaxel in this patient population, it was efficacious and safe.
    Among the 21 patients enrolled to the trial, approximately half had platinum-refractory disease and half previously received treatment with antiangiogenics....
The combination is currently under further exploration in the phase 3 OVAL trial (NCT03398655), where it is being compared with paclitaxel alone in patients with recurrent platinum-resistant ovarian cancer.
    “We are pleased to receive FDA fast track designation for [VB-111] in platinum-resistant ovarian cancer. The fast track designation can facilitate the process toward potential registration and, importantly, may help expedite the time to market for [VB-111], if approved,” Dror Harats, MD, chief executive officer of VBL Therapeutics, stated in a press release. “The readout of the PFS primary end point in the OVAL trial will be an important milestone for VBL in the second half of [2022]. We believe that, if positive, this will support a biologics license application submission to the FDA.”
OVAL recently completely enrollment of 409 patients, and the trial is being conducted at cancer centers throughout the United States, Europe, Israel, and Japan. 

Friday, May 6, 2022

2022 TTT Retreat Applications/Forms


This year our annual Turning the Tide Ovarian Cancer Retreat will be held at beautiful, Essex Woods Meeting and Retreat Center, in Essex, MA.

The links are available at the bottom of the screen for you to download the application instructions, the application itself, the health history form and the consent form. You can print it out and send it back to me via email or mail. If you have trouble opening the link or you are without the ability to print, please contact me at mastrangelom@comcast.net so that I can send you a hard copy.

The acceptance process is not first-come, first-serve. Please make sure that if you are mailing the hard copy of your forms, it must be received by Tuesday, May 24th so that we can contact you by Friday, May 27th by email or 'phone to confirm your spot. We will have a wait list available.

Do not send any payment at this time - please wait until your spot has been confirmed.

·      Again, only after you have been notified of your spot, please send your check for $250 (or any amount – we want all women to attend regardless of ability to pay) payable to: Turning the Tide Ovarian Cancer Retreats Inc.

 NOTE: If you need to request a scholarship (assistance for payment) please check the box on the application form.

We so look forward to your application! 

Here are the links to each document:

Application Instruction

Application

Health Form

Consent Form



Monday, April 11, 2022

Online tool helps ovarian cancer patients feel more in control of symptoms

This is an edited version of an article published on ScienceDaily February 8, 2022.

An online symptom management tool that harnesses the problem-solving benefits of expressive writing could help women with ovarian cancer better manage complex symptoms, according to a new study led by a University of Pittsburgh and UPMC nurse-scientist.

Published in the Journal of Clinical Oncology, the study found that patients who used nurse-led and self-directed versions of the tool reported a better sense of control over symptoms compared to enhanced usual care.

"Women with ovarian cancer experience an average of 14 concurrent symptoms, so symptom management is very complex. It can be overwhelming for patients and challenging for providers, who may not have time to address these symptoms in a typical 15-minute appointment," said lead author Heidi Donovan, Ph.D., R.N., professor of health and community systems in Pitt's School of Nursing and obstetrics, gynecology and reproductive services in the School of Medicine. "That's why we developed a symptom management approach outside of a normal clinical setting, from the comfort of a woman's own home."

According to Donovan, ovarian cancer is a "low incidence, high impact cancer." In 2022, about 20,000 women will be diagnosed with ovarian cancer in the U.S., and more than 12,000 will die. For many patients who are treated successfully, the cancer recurs after two to three years.

"There's a vast difference in quality of life between patients who manage symptoms successfully and those who don't, both throughout chemotherapy and afterwards," said Donovan, who is also director of the Gynecologic Oncology Family CARE Center at UPMC Magee-Womens Hospital. "Effective symptom management requires that patients follow directions from providers but also be willing to communicate, make adjustments and try new strategies."

Donovan and her team developed a new symptom management approach called Written Representational Intervention to Ease Symptoms, or WRITE Symptoms, which guides patients to reflect on how they experience a symptom: what causes it, what makes it worse, how it feels, how it impacts their daily life and how they've tried to manage it.

"The WRITE approach blends health psychology with educational principles," explained Donovan. "The process of talking or writing about a symptom in a systematic way can help women understand which management strategies work and which don't. Using evidence-based symptom management techniques, we then help patients develop strategies for addressing target symptoms. Later, patients review the strategies and assess if changes need to be made. It's a very iterative process."

The researchers recruited 497 patients with recurrent or persistent ovarian, fallopian tube or primary peritoneal cancer. After participants completed surveys about symptom burden, controllability and quality of life and selected three target symptoms they wanted better control of, they were randomly assigned to one of three groups.

One group completed a nurse-led version of the WRITE intervention, in which nurses guided patients through the process via an asynchronous web-based message board. The second group directed themselves through a fully computer-mediated version of WRITE. The third, or enhanced usual care group, did not complete WRITE and acted as a control.

The analysis found that both WRITE interventions improved women's sense of control over their symptoms after eight weeks, and these measures were significantly greater compared with enhanced usual care.

"To see the same benefits in both the nurse-led and fully computer-mediated versions of the program is really powerful," said Donovan. "We also found that the self-led program was much more efficient: People were able to develop a symptom management plan in about 30 minutes compared to a few weeks with the asynchronous, nurse-led version."

The researchers are now developing a mobile health app that will train family members and other caregivers to help their loved ones with ovarian cancers better manage symptoms. Based on the computer-mediated version of WRITE, the app will guide users through questionnaires and problem-solving exercises, and it will feature disease-specific modules and core modules that could apply to patients with any chronic disease. For patients who need extra support, there will also be an option to connect with providers. According to Donovan, this app could be offered to families of gynecology cancer outpatients in the next year or so.


Story Source:

Materials provided by University of PittsburghNote: Content may be edited for style and length.


Thursday, April 7, 2022

Conjugate Therapy Produces Remissions in One-Third of Patients with Drug-Resistant Ovarian Cancer, Study Results Show

This is a news release from Dana Farber Cancer Institute, published on March 19, 2022

In a clinical trial involving patients with ovarian cancer previously treated with platinum-based chemotherapy, a novel “conjugate” therapy produced a substantially better response than standard treatments, investigators at Dana-Farber Cancer Institute...

The agent, mirvetuximab soravtansine, generated an objective response – a measurable decrease in cancer burden – in nearly 33% of patients participating in the trial. That compares with response rates in the single digits for current treatments in patients whose ovarian cancer doesn’t respond to platinum-based chemotherapy.

The novel agent is one of a growing number of antibody-drug conjugates, or ADCs, which consist of a drug linked to an antibody that directly targets the cancer cell. Mirvetuximab connects an antibody targeting the folate receptor alpha molecule on high-grade serous ovarian cancers to a drug molecule called DM4 that disrupts microtubule formation. (Microtubules are major components of the cytoskeleton that give shape and structure to cells.) The folate receptor protein is far more abundant in some tumor cells than normal cells, making it an attractive target for cancer drugs.

The trial, titled the SORAYA study, enrolled 106 patients with platinum-resistant high-grade serous ovarian cancer that highly expressed folate receptor alpha. All patients were required to have previously received bevacizumab, a drug that blocks tumors from forming blood vessels to take in more oxygen and nutrients. The participants had been treated with up to three prior treatments for their ovarian cancer.

After a median follow-up of 8.1 months, 32.4% of participants had an objective anti-cancer response, including five who had a complete response, or the disappearance of all signs of cancer. The median duration of response is currently 6.9 months.

Mirvetuximab was well-tolerated by study participants. The most common adverse side effects associated with the treatment were blurred vision, keratopathy (a non-inflammatory condition of the eye), and nausea.

“These data have the potential to be transformative for ovarian cancer patients and their physicians,” said Ursula Matulonis, MD, chief of the Division of Gynecologic Oncology at Dana-Farber and co-principal investigator of the SORAYA study, who will present the findings at the SGO. “In the platinum- resistant setting and particularly in later-line treated patients, response rates with available therapy are in the single digits with significant toxicities. With an objective response rate above 30%, a duration of response of around six months, and a treatment-related discontinuation rate of 7%, mirvetuximab shows impressive activity and tolerability for patients with platinum-resistant ovarian cancer.  These data support the future of mirvetuximab as the potential standard of care for patients with folate receptor alpha positive ovarian cancer.”