Verastem Oncology Launches HCP and Patient Reimagine Campaign to Increase Awareness of AVMAPKI® FAKZYNJA® CO-PACK for KRAS-Mutated Recurrent Low-Grade Serous Ovarian Cancer

BOSTON--(BUSINESS WIRE)--Apr 30, 2026--

Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with RAS/MAPK pathway-driven cancers, today announced the launch of its Reimagine Recurrent Low-Grade Serous Ovarian Cancer (LGSOC) campaign for AVMAPKI ® FAKZYNJA ® CO-PACK (avutometinib capsules; defactinib tablets), the first and only treatment specifically approved by the U.S. Food and Drug Administration (FDA) for adult patients with KRAS-mutated recurrent LGSOC who have received prior systemic therapy. The integrated campaign encourages healthcare professionals (HCPs) and patients to rethink what may be possible at and beyond the earliest recurrence for people living with KRAS-mutated recurrent LGSOC.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260428101589/en/

LGSOC is a rare and distinct form of ovarian cancer, with unique biology and clinical behavior different from other ovarian cancers. Its tumor growth is primarily driven by the RAS/MAPK pathway with activating mutations, most commonly in the KRAS gene, found in many cancers that often correlate with poor prognosis. Approximately 30% of patients with LGSOC have a KRAS mutation, making it the most common type of gene mutation in the disease. Patients with LGSOC often experience delays in diagnosis and have historically had limited treatment options specifically for their disease.

“The Reimagine Recurrent LGSOC campaign shifts how we think about KRAS-mutated recurrent LGSOC treatment and supporting both patients and healthcare professionals in rethinking what may be possible at and beyond the earliest recurrence,” said Dan Paterson, president and chief executive officer at Verastem Oncology. “The FDA’s accelerated approval of AVMAPKI FAKZYNJA CO-PACK marked an important step forward for patients with KRAS-mutated recurrent LGSOC, underscoring the need for treatments specifically developed for this population. With this campaign, we’re building on that momentum to further inform treatment decisions and support patients throughout their care journey.”

The Reimagine campaign was informed by insights from patients and HCPs, highlighting the need for both emotional resonance and practical, accessible information. For HCPs, the campaign encourages re-evaluation of treatment approaches in the context of a treatment specifically approved by the FDA for KRAS-mutated recurrent LGSOC. For patients, it reflects a desire not only to manage their condition, but to envision a future shaped by progress and meaningful life milestones.

“Patients with KRAS-mutated recurrent LGSOC have historically had limited resources tailored to their specific experience,” said Linda Stamler, vice president of marketing at Verastem Oncology. “The Reimagine Recurrent LGSOC campaign was developed to help identify and support patients who may be appropriate for treatment with AVMAPKI FAKZYNJA CO-PACK. Through this campaign, we are offering resources such as patient stories, tools to help manage side effects, videos explaining mechanism of action and dosing, and guides to help set treatment expectations so patients and HCPs feel more informed and supported.”

For more information, HCPs can visit https://www.avmapkifakzynjaco-pack-hcp.com/ and patients can visit https://www.avmapkifakzynjaco-pack.com/.

About Low-Grade Serous Ovarian Cancer (LGSOC)

LGSOC is a rare ovarian cancer that is insidious and persistent. LGSOC is distinct and different from high-grade serous ovarian cancer (HGSOC) and requires different treatment. LGSOC is highly recurrent and less sensitive to chemotherapy compared to HGSOC. Approximately 6,000-8,000 women in the U.S. and 80,000 worldwide are living with this disease. LGSOC affects younger women with bimodal peaks of diagnosis at ages between 20-30 and 50-60 and has a median survival of approximately ten years. Approximately 70 percent of LGSOC shows RAS pathway-associated mutations, and 30 percent of people with LGSOC have a KRAS mutation. The majority of patients report a negative impact of LGSOC on their mental and physical health, fertility, and long-term quality of life.

About AVMAPKI and FAKZYNJA Combination Therapy

AVMAPKI (avutometinib) inhibits MEK kinase activity while also blocking the compensatory reactivation of MEK by upstream RAF. RAF and MEK proteins are regulators of the RAS/RAF/MEK/ERK (MAPK) pathway. Blocking RAF and/or MEK activates FAK, a key mediator of drug resistance. FAKZYNJA (defactinib) is a FAK inhibitor and together, the avutometinib and defactinib combination was designed to provide a more complete blockade of the signaling that drives the growth and drug resistance of RAS/MAPK pathway-dependent tumors.

The U.S. Food and Drug Administration (FDA) approved AVMAPKI ® FAKZYNJA ® CO-PACK (avutometinib capsules; defactinib tablets) for the treatment of adult patients with KRAS-mutated recurrent LGSOC who have received prior systemic therapy on May 8, 2025. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Verastem is conducting RAMP 301 (GOG-3097/ENGOT-ov81/GTG-UK) (NCT06072781), an international Phase 3 confirmatory trial evaluating the combination of avutometinib and defactinib versus standard chemotherapy or hormonal therapy for the treatment of recurrent low-grade serous ovarian cancer (LGSOC) with and without a KRAS mutation. Verastem is also evaluating avutometinib plus defactinib with standard-of-care chemotherapy as a potential treatment in the first-line for patients with advanced pancreatic cancer (RAMP 205; NCT05669482). Avutometinib and defactinib are not approved by the FDA or any other regulatory authority, either in combination or with other therapies, for any of these investigative uses. Neither avutometinib nor defactinib are approved by the FDA or any other regulatory authority on a stand-alone basis for any use.

AVMAPKI FAKZYNJA CO-PACK U.S. Indication

Indication

AVMAPKI FAKZYNJA CO-PACK is indicated for the treatment of adult patients with KRAS -mutated recurrent low-grade serous ovarian cancer (LGSOC) who have received prior systemic therapy.

This indication is approved under accelerated approval based on tumor response rate and duration of response . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Important Safety Information

Warnings and Precautions

Adverse Reactions

The most common (≥ 25%) adverse reactions, including laboratory abnormalities, were increased creatine phosphokinase, nausea, fatigue, increased aspartate aminotransferase, rash, diarrhea, musculoskeletal pain, edema, decreased hemoglobin, increased alanine aminotransferase, vomiting, increased blood bilirubin, increased triglycerides, decreased lymphocyte count, abdominal pain, dyspepsia, dermatitis acneiform, vitreoretinal disorders, increased alkaline phosphatase, stomatitis, pruritus, visual impairment, decreased platelet count, constipation, dry skin, dyspnea, cough, urinary tract infection, and decreased neutrophil count.

Drug Interactions

Use in Specific Populations

Click here for full Prescribing Information.

About Verastem Oncology

Verastem Oncology (Nasdaq: VSTM) is a biopharmaceutical company committed to developing and commercializing new medicines to improve the lives of patients diagnosed with RAS/MAPK pathway-driven cancers. Verastem markets AVMAPKI ® FAKZYNJA ® CO-PACK in the U.S. Our pipeline is focused on novel small molecule drugs that inhibit critical signaling pathways in cancer that promote cancer cell survival and tumor growth, including RAF/MEK inhibition, FAK inhibition, and KRAS G12D inhibition. For more information, please visit www.verastem.com and follow us on LinkedIn.

Forward-Looking Statements

This press release includes forward-looking statements. These forward-looking statements generally can be identified by the use of words such as “anticipate,” “expect,” “plan,” “could,” “may,” “believe,” “estimate,” “forecast,” “goal,” “project,” and other words of similar meaning. Such forward-looking statements address various matters about, among other things, Verastem Oncology’s programs and product candidates, strategy, future plans and prospects, including statements related to the potential for and timing of commercialization of product candidates, the expected outcome and benefits of the Company’s collaboration with GenFleet Therapeutics (Shanghai), Inc., the timing of commencing and completing trials and compiling data, the expected timing of the presentation of data by the Company and the potential clinical value of various of the Company’s clinical trials. Each forward-looking statement contained in this press release is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statement. Applicable risks and uncertainties include, among others: the uncertainties inherent in research and development, such as the possibility of negative or unexpected results of clinical trials; that we may not see a return on investment on the payments we have and may continue to make pursuant to the collaboration and option agreement with GenFleet, or that GenFleet may fail to fully perform under the agreement; that we may not be successful in our continued commercialization of AVMAPKI FAKZYNJA CO-PACK; that the development and commercialization of our product candidates may take longer or cost more than planned, including as a result of conducting additional studies or our decisions regarding execution of such commercialization; that data may not be available when expected; risks associated with preliminary and interim data, which may not be representative of more mature data; risks associated with the recent changes in administration policy or actions that may create regulatory uncertainty that may adversely affect our business; risks associated with the current administration’s reductions to the FDA’s workforce and any subsequent reductions that may lead to disruptions and delays in the FDA’s review and oversight of our product candidates and impact the FDA’s ability to provide timely feedback on our development programs; that our product candidates may not receive regulatory approval, become commercially successful products, or result in new treatment options being offered to patients; and the risks identified under the heading "Risk Factors" as detailed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, as filed with the Securities and Exchange Commission (SEC) on March 4, 2026, as well as the other information we file with the SEC, are possibly realized. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at www.sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this press release, and we undertake no obligation to update or revise any of these statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

Verastem Oncology Launches HCP and Patient Reimagine Campaign to Increase Awareness of AVMAPKI® FAKZYNJA® CO-PACK for KRAS-Mutated Recurrent Low-Grade Serous Ovarian Cancer

Verastem Oncology Launches HCP and Patient Reimagine Campaign to Increase Awareness of AVMAPKI® FAKZYNJA® CO-PACK for KRAS-Mutated Recurrent Low-Grade Serous Ovarian Cancer

The soccer coach had blocked himself from sportsbooks by the time he found prediction markets.

The tax accountant said he “got the same high” on those platforms that he got from gambling. “That was how I relapsed — with Kalshi and Polymarket. I lost a bunch of money.”

The rapid growth of prediction markets has sparked a high-stakes debate that is playing out in courts and legislatures all over the country. Operators of those companies believe they should be regulated like the stock exchange because of federal law and their customer-to-customer structure, while sportsbooks and state officials think they should be supervised the same way as sports gambling platforms.

While that argument continues with no sign of resolution, the clinicians who treat gambling disorders are more concerned about what they are seeing with their patients. In their spaces, when it comes to sports gambling and prediction markets, the end result is virtually the same.

Two gambling addicts who spoke to The Associated Press — the soccer coach and tax accountant — say they had relapses on prediction markets after they took legal action to protect themselves from the allure of sports betting. They are being identified by their occupations because of the sensitivity of their situations. Their stories reflect what experts say they see with some of their clients.

“There may be real differences in how these products are defined or regulated, but in the therapy room, we are often seeing the same cycle of anticipation, action and reaction play out again and again,” said Dr. Cynthia Grant, the vice president of clinical for Birches Health, which operates a national network of providers for treating gambling addiction.

“I sometimes think of it like different doors into the same room. The label on the door may change, but once someone’s inside, the experience can feel very familiar.”

Sportsbooks and prediction markets offer a lot of similar options. Wagers on games, individual performances and other possibilities. But the format is different.

Sportsbooks have in-house experts who set odds that dictate payouts for winning bets. It's the house versus the gamblers. Traders on predictions markets swap contracts of yes-or-no questions, and profits and losses are dictated by the market. Win a “yes” holding on an event contract where most of the market guessed “no,” and the payout is bigger. Prediction markets generally make money through fees on contracts.

For addicts, they are two paths to the same result.

The soccer coach who spoke to the AP started gambling when he was 16. Small bets against friends in his New York neighborhood, everything from cards to basketball and tennis. When he turned 18, he started going to casinos and making bets at sportsbooks. Amid mounting losses, he turned to prediction markets.

“I would be in all this debt and get a paycheck for $2,000 on a Friday and it would be gone by Saturday or Sunday,” said the coach, 21. “I wouldn’t have money to fill up my gas tank.”

He was struggling with loans and maxed-out credit cards while working and going to college before he stepped away in January to confront his addiction problems, which also included smoking marijuana.

He joined Gamblers Anonymous, and he was told he had to stop associating with people who gamble.

“For a younger crowd, that’s difficult because it’s everywhere,” the coach said. “My friends from childhood — most of them all gamble."

The coach and the tax accountant had formally self-excluded from sportsbooks before they started trading on prediction markets. Self-exclusion programs provide an opportunity for gamblers to ban themselves from gambling facilities and betting apps. They are offered in many states as part of gambling regulations, but there is no widely adopted national system.

The landscape for self-exclusion programs becomes even more fragmented when predictions markets are included. Kalshi started a voluntary opt-out program when it launched a customer protection hub in March 2025, and it's one of several platforms — including Polymarket — collaborating on a national self-exclusion program for prediction markets. But it's not clear if that program would ever overlap with the systems used by state gambling regulators.

The accountant, 33, said his gambling problems started after New York launched legalized mobile sports betting in January 2022. He had “a boatload of debt” in August 2023 when he told his then-fiancée about what was going on with him.

She married him anyway. Looking to save money after the wedding, they moved into a rental house owned by his parents. He self-excluded from sportsbooks. Then, after the couple lost their first pregnancy, the accountant started day-trading before signing up for Kalshi.

“Prediction markets are the same thing packaged in a different way,” the accountant said. “It’s a dangerous loophole. ... How can you do all that and say you’re not a sportsbook?”

Tennis was his go-to sport — he liked the speed of the matches — before he went to rehab in Virginia last year.

He had a relapse in December when he downloaded Polymarket and made a free $10 wager. He was confronted by his wife, who had his email connected to her phone and reached out to his sponsor.

While there has been no substantive research into the effect of prediction markets on sports gambling addiction, the experiences of the coach and the accountant are not uncommon for treatment experts.

“You’re seeing a lot of the same behaviors, whether it’s a prediction market or it’s gambling,” said Jody Bechtold, the CEO of The Better Institute, a Pennsylvania practice that works with people impacted by gambling disorders. “You’re seeing, you know, wagering more and more. Chasing losses, so ‘Oh, today was a bad day, I have to work tomorrow at the prediction markets to get my money back.’ ... The lies, the secrecy, and that it’s impacting everyday life.”

Kalshi spokeswoman Elisabeth Diana highlighted its programs for responsible trading — such as trading breaks and self-limits — and said it's working on other measures to further facilitate healthy trading behavior.

Compared to casinos, Diana said, Kalshi is “fairer, more transparent, and less predatory.”

"There is no house that wins when customers lose,” she said. "This means that Kalshi doesn’t hook losers and penalize winners.”

A message was left seeking comment from Polymarket.

Sports have become a major category for prediction markets. Kalshi had more than $2 billion in total trading volume on this year’s NCAA men’s basketball tournament, according to Diana. Michigan’s 69-63 victory over Connecticut in the championship had $10.6 million in volume on Polymarket.

The U.S. market for sports-focused event contracts could grow to approximately $1.1 trillion in annual volume, according to a Bank of America report.

“A year ago, if you said prediction markets, I mean I don’t know what that is, I don’t see it,” said Dr. Timothy Fong, the co-director of the UCLA Gambling Studies Program. “Now we’re starting to see it more and more in our patients that come into the clinic. And it’s usually not one, it’s multiple platforms they’re betting on, right? ... When you have something that’s available, that’s accessible, that’s anonymous, is super easy to use, multiple times in a day, of course that’s going to raise the risk of addiction for any human on Earth.”

There are multiple ongoing lawsuits involving states and prediction markets, and the ramifications of the legal dispute are being felt on a variety of levels.

Marlene Warner, the CEO of the Massachusetts Council on Gaming and Health — a private nonprofit health organization that provides educational programs on gambling along with other services — said the situation with prediction markets “feels a bit like the wild, wild west right now.”

“We’re very used to like going to our state regulator or, you know, seeing a process go through where all of a sudden now you’re like, ‘OK, a piece of legislation has outlined what is appropriate for a licensed sports betting operator to do,’" Warner said. “And then you see the regulation come into place. And so you can track it. But right now, nobody knows kind of what the limits are.”

In most states with legal sports gambling, it is limited to ages 21 and older, while prediction markets are open for 18- to 20-year-olds with some exceptions. Prediction markets also have a presence in states where sports betting is illegal, including Texas and California.

“I don’t know enough frankly, we don’t know enough, nothing’s been studied about them, I can’t tell you whether they’re more less or exactly the same in terms of risk level,” Warner said. “But what I do know is they're in a very gray, unregulated space and that alone makes it difficult.”

Prediction markets fall under the jurisdiction of the federal Commodity Futures Trading Commission, which has a regulation that prohibits an event contract “that involves, relates to, or references terrorism, assassination, war, gaming, or an activity that is unlawful under any state or federal law.”

CFTC chairman Michael Selig is backing prediction markets in their legal proceedings against several states, asserting the commission's “exclusive jurisdiction over these markets.”

While that argument continues, the soccer coach and tax accountant are rebuilding their lives — while doing their best to stay vigilant with their addictions.

“You have to face this stuff or it just keeps getting worse,” the coach said.

AP sports: https://apnews.com/sports

The Associated Press receives support from Charles Schwab Foundation for educational and explanatory reporting to improve financial literacy. The independent foundation is separate from Charles Schwab and Co. Inc. The AP is solely responsible for its journalism.

In this photo made with a long exposure, a laptop displays trades made on the Kalshi website on Thursday, April 16, 2026, in Portland, Ore. (AP Photo/Jenny Kane)

HOLD The prediction market app Kalshi is displayed on a mobile phone Thursday, April 16, 2026, in Chicago. (AP Photo/Erin Hooley)

FILE - An advertisement for prediction market platform Kalshi hangs at 13th and L Streets in northwest Washington, April 1, 2026. (AP Photo/Allison Robbert, File)