Ryan Scott

Dr. Megan Menon explains how patients can verify the authenticity of online prescription purchases for their cancer treatment.

How Patients With Cancer Can Avoid Counterfeit Therapeutics Online

Counterfeit drugs are estimated to be a $4 billion a year industry, with only 5% of the approximately 35,000 online pharmacies being accredited, Dr. Megan Menon explained in an interview CURE®.

The risk for counterfeit drugs disproportionately affects younger patients, Menon, executive director of pharmacy at Roswell Park Comprehensive Cancer Center in Buffalo, New York, emphasized.

“The younger patient population is at higher risk, and it's probably because we're so used to going online for everything,” Menon said. “I go to the store, and I see something, buth then look at my phone to see if I can find it cheaper somewhere else. So really, [there is] a lot of comfort with just going online to find something cheaper. I don't know that we're quite aware of the number of scam sites that are out there.”

In the interview, Menon spoke with CURE about how patients can avoid counterfeit drugs online and what resources are available to them.

The first thing to do if you're going to a website is [to see if] there's a link to the Alliance for Safe Online Pharmacies [https://asopfoundation.pharmacy/]. There, you can see if the pharmacy that you're looking at is accredited. The other thing is, if you get to a website and it says they don't require a prescription for a medication, especially an oral oncolytic, run away because that is absolutely not a legitimate website. If you have questions, like if they do require a prescription but it's not on the Alliance for Safe Online Pharmacies website, reach out to your care team.

A lot of hospitals, a lot of clinics and providers, are aware of this risk, so they can help you determine if it's a legitimate website that you're going to. If you're going to these websites just trying to find a cheaper option — because these agents are very expensive — they will have resources to help you get the financial aid that you need to be able to afford your medications.

Transcript has been edited for clarity and conciseness.

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Articles

Counterfeit drugs represent a significant issue, with only a small fraction of online pharmacies being accredited. Younger patients are particularly vulnerable due to their comfort with online shopping. To avoid counterfeit drugs, patients should verify pharmacy accreditation through the Alliance for Safe Online Pharmacies and be cautious of sites not requiring prescriptions. Healthcare providers can assist in identifying legitimate sources and offer financial aid resources for expensive medications. Awareness and education are crucial in mitigating the risks associated with counterfeit drugs.

Tuspetinib plus venetoclax and azacytidine showed safety and antileukemic activity in newly diagnosed AML, with early complete remissions in the TUSCANY trial.

Treatment with tuspetinib (HM43239) in combination with standard of care dosing of Venclexta (venetoclax) and Vidaza (azacytidine), referred to as TUS+VEN+AZA, among patients with newly diagnosed acute myeloid leukemia (AML) showed acceptable safety and activity.

Data garnered from the phase 1/2 TUSCANY trial were shared in a press release from Aptose Biosciences Inc. The release went on to note that the triplet is being developed for the treatment of large, diverse populations of patients with newly diagnosed AML who are not eligible for induction chemotherapy.

The company announced the launch of the TUSCANY trial and the initiation of dosing in the first cohort of newly diagnosed patients with AML in January 2025. The initial dose of TUS at 40 milligrams (mg) was administered as part of the triplet combination, with early data indicating safe outcomes and antileukemic activity. 

“These are very promising early results from the TUSCANY trial of TUS+VEN+AZA and the first indicators of the safety and efficacy we expected to see in newly diagnosed AML patients,” said Dr. Rafael Bejar, chief medical officer of Aptose. “To achieve a complete remission [CR] in Cycle 1 in a subject harboring a TP53 mutation — one of the most adverse forms of AML — is particularly encouraging. With enrollment ongoing in the TUSCANY study, we look forward to reporting additional data as it becomes available.”

Four patients with newly diagnosed AML have received the 40 mg dose of TUS within the triplet regimen to date. Three patients with FLT3 wild-type disease completed Cycle 1 of treatment without dose-limiting toxicities (DLTs) or adjustments. Two participants achieved CR by the end of Cycle 1, while the third participant showed a marked reduction in bone marrow leukemic blasts and remains on therapy in Cycle 2. 

Notably, a patient with biallelic TP53 mutations and a complex karyotype also achieved CR. The fourth patient, who harbors FLT3-ITD and NPM1 mutations, is currently in Cycle 1 and has not yet been evaluated for response. Pharmacokinetic analyses of TUS indicate that plasma levels remain stable despite the addition of AZA, ensuring predictability and eliminating the need for dose modifications due to PK interactions.

“TUS+VEN+AZA triplet therapy has the potential to treat large AML patient populations, including those with traditionally difficult-to-treat mutations, and improve patient outcomes right from the outset of treatment,” Dr. William G. Rice, chairman, president and chief executive officer of Aptose emphasized in the press release. “The ability to treat such diverse AML populations — including FLT3 wildtype patients — with a favorable safety profile and without having to alter the standard of care dosing, differentiates our drug from many AML drugs in development.”

The goal of the phase 1/2 TUSCANY trial, which is evaluating TUS+VEN+AZA triplet therapy, is to create an improved frontline therapy for patients with newly diagnosed AML, specifically across diverse AML populations; the treatment is meant to be durable and well tolerated. Previous investigations of TUS-based approaches, as evaluated in the APTIVATE trials, showed favorable outcomes; further evaluations found that TUS+VEN also demonstrated "favorable safety and broad activity in diverse relapsed or refractory AML populations that went beyond the more prognostically favorable NPM1 and IDH mutant subgroups," according to the press release. Notably, patient responses to TUS were also recorded in patients with prior-VEN and prior-FLT3 inhibitor therapies, as well as in patients with highly adverse TP53 and RAS mutations and those with mutated or unmutated FLT3 genes.

TUSCANY is designed to test various doses and schedules of TUS when given in combination with standard dosing of AZA and VEN for patients with AML who are ineligible to receive induction chemotherapy. The 40 mg once-daily administration of the oral agent will be given on 28-day cycles, with dose escalations planned after a safety review of each dose level. Clinical sites across the United States are beginning to enroll patients in the trial with an anticipated enrollment of 18 to 24 patients by mid-late 2025.

According to the release, data will be released as it becomes available.

For more news on cancer updates, research and education,

don’t forget to subscribe to CURE®’s newsletters here.

The combination of tuspetinib (HM43239), venetoclax, and azacytidine (TUS+VEN+AZA) shows promising safety and efficacy in treating newly diagnosed acute myeloid leukemia (AML) patients ineligible for induction chemotherapy. Early results from the TUSCANY trial indicate complete remission in some patients, including those with adverse mutations like TP53. The trial aims to establish a durable, well-tolerated frontline therapy for diverse AML populations. Pharmacokinetic stability of tuspetinib ensures predictable dosing without modifications. Enrollment is ongoing, with further data anticipated as the trial progresses.

Treatment with tuspetinib in combination with Venclexta and Vidaza in newly diagnosed acute myeloid leukemia showed safety and antileukemic activity.

Tuspetinib Triplet Is Safe and Has Antileukemic Activity in Newly Diagnosed AML 

Dr. Catherine Wu discussed the unique aspects of clear cell renal cell carcinoma and the challenges of targeting it with a vaccine. 

Personalized Cancer Vaccine Demonstrates Responses in Kidney Cancer 

Among patients with clear cell renal cell carcinoma, a form of kidney cancer, a personalized cancer vaccine demonstrated anti-cancer immune responses, according to recent study findings published in 

The study enrolled nine patients with stage 3 and 4 clear cell renal cell carcinoma, who received a personalized cancer vaccine following the surgical removal of their tumors. The patients who received the vaccine experienced anti-cancer immune responses, with all patients remaining cancer-free at a median data cut-off of 34.7 months, or nearly three years, according to researchers.

CURE® spoke with the study’s co-senior author, Dr. Catherine Wu, chief of the Division of Stem Cell Transplantation and Cellular Therapies at Dana-Farber Cancer Institute, and institute member at the Broad Institute of MIT and Harvard, in Boston. In an interview, she noted that the current standard of care for this patient population is surgery.

“And then they wait,” she continued. “And 30% to 40% of those patients will relapse over time, within two years.”

Wu spoke with CURE about the unique aspects of clear cell renal cell carcinoma that make it a particularly challenging potential target for cancer vaccines.

Melanoma is so often a poster child for cancer immunotherapy. There are some unique aspects of melanoma, meaning that it's what we call a high mutation burden tumor. There are lots of different mutations to choose from. We kind of have an easier time creating a vaccine.

With renal cell [carcinoma], it's a much lower tumor mutation burden, so the bar is higher for us to work a little bit harder. One of the key things about the study is that we demonstrate that even with a lower-mutation burden tumor, we still are successful in consistently generating a vaccine for every patient that we treated; it can still generate a strong immune response

“A neoantigen vaccine generates antitumour immunity in renal cell carcinoma” by Dr. David A. Braun et al., 

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Dr. Nataliya Uboha explained the benefit of treatment with Krazati combined with Erbitux in KRAS G12C–mutant metastatic colorectal cancer.

Krazati and Erbitux Combo Benefits KRAS G12C+ Metastatic Colorectal Cancer 

Among patients with heavily pretreated patients with KRAS G12C–mutant unresectable or metastatic colorectal cancer, treatment with Krazati (adagrasib) to Erbitux (cetuximab) continued to show meaningful efficacy, according to data from the phase 1/2 KRYSTAL-1 trial, Dr. Nataliya Uboha explained.

At the 2025 ASCO Gastrointestinal Cancers Symposium, Uboha and others shared that at a median follow-up of 20.4 months, the overall response rate was 34% by blinded independent central review and 43% by investigator assessment. Meanwhile, disease control rates were 85% and 86%, respectively.

Overall response rate: the percentage of patients who have a complete or partial response to a treatment.

Disease control rate: the percentage of patients who have a complete, partial or stable response to a cancer treatment.

Uboha is a medical oncologist at UW Health, as well as an associate professor and researcher in the Department of Medicine at the University of Wisconsin School of Medicine and Public Health. In an interview with CURE, she sat down to discuss the KRYSTAL-1 study which evaluated patients with KRAS G12C-mutated metastatic colorectal cancer and highlighted what makes Krazati combined with Erbitux a potential treatment option for these patients.

We are seeing a very good signal of activity with these two drugs in patients with colorectal cancer with this mutation. Initially Krazati was developed primarily for patients with lung cancer; however, we see mutations in the KRAS gene with much more frequently in lung cancer. Subsequently, we were studying Krazati in patients with gastrointestinal cancers, in particular colorectal cancer. We have found out that when we combine this drug with an anti-EGFR drug, we see much better efficacy, and much better activity. 

What we have learned from the KRYSTAL-1 trial is that patients with colorectal cancer who have had chemotherapy in the past and whose cancer continue to grow and as well as carry this mutation have a good chance of responding to this treatment. This is a treatment that does not include chemotherapy, so it is relatively well tolerated, and it is quite active in patients who have tumors with this particular mutation.

Ryan Scott

How Patients With Cancer Can Avoid Counterfeit Therapeutics Online

Tuspetinib Triplet Is Safe and Has Antileukemic Activity in Newly Diagnosed AML

Personalized Cancer Vaccine Demonstrates Responses in Kidney Cancer

Krazati and Erbitux Combo Benefits KRAS G12C+ Metastatic Colorectal Cancer

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