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CURE’s gastric cancer page is a go-to resource for oncology news and updates in the world of gastric cancer Here, readers will find cancer articles, videos, podcasts, and more with expert insight into the latest treatments and research in gastric cancer.

Last week, we saw some research regarding how a popular tool used to plan breast cancer treatment may be misguiding therapy for Black women, as well as an update on when we can expect to see a new cancer vaccine be readily available for patients.

And on the FDA front, we’ll discuss a priority review for Enhertu for patients with HER2-positive solid cancers, as well as a fast track designation for a new drug duo in the lung cancer space.

Cancer Vaccine Likely ‘Several Years’ Away From Wide Availability

ELI-002 is a vaccine being investigated for the treatment of patients with KRAS-mutant pancreatic or colorectal cancers. While cancer vaccines have been in the headlines a lot in recent months, this one, at least, is still a ways away from being readily available for patients across the United States.

Findings from a phase 1 trial showed that the vaccine could be beneficial for this patient population, and now, a phase 2 trial recently started that will evaluate the efficacy of an injection version of ELI-002, compared to observation. The first patient was dosed in the trial in January 2024, so it could still be several more years until the drug is available, Dr. Christopher Haqq, chief medical officer and vice president, head of research and development at Elicio Therapeutics, said in an interview with CURE®.

“We'll be talking to the regulators like the US Food and Drug Administration and others around the world to align on the data that we'll need to provide for a marketing application. And so, we haven't had that input yet. So I can't give an exact answer for you (on when the vaccine will be commercially available). But we'll work as fast as possible. It's even possible that the type of evidence that we gather in this randomized study could serve that purpose. But we won't know until we have further discussion,” he said.

Test May Be ‘Misguiding’ Breast Cancer Treatment for Black Women

A recent study showed that the 21-gene breast recurrence score may lead clinicians away from prescribing chemotherapy to Black women who may benefit from the treatment.

The 21-gene breast recurrence score is the standard test to help guide treatment decisions for patients with estrogen receptor-positive (also known as ER-positive) disease. Most patients with ER-positive cancer undergo hormone therapy, but the outcomes for this test may help decide if a patient would benefit from additional chemotherapy, too. Now, findings from a recent study discovered that Black women — and younger Black women, in particular — may be missing out on chemotherapy that they could potentially benefit from.

Now, this research team is conducting further research looking at potential molecular differences in breast cancer in Black women, as well as how other social disparities could be playing into an increased risk of breast cancer death in these women.

FDA Grants Priority Review to Enhertu for HER2-Positive Solid Cancers

The Food and Drug Administration granted a priority review for a supplemental biologics license to Enhertu for the treatment of patients with previously treated metastatic HER2-positive solid tumors that cannot be removed via surgery. Basically what that means is that the drug showed promise in a clinical trial, and now the FDA will work with the pharmaceutical company developing the drug to expedite the review and potential approval of the agent. The agency plans on making its decision on whether or not Enertu will be approved some time in the second quarter of this year.

Enertu is an antibody drug conjugate, which is a type of drug that works by finding and binding to certain proteins found on cancer cells — in this case, the HER2 protein. The drug was previously approved for patients with lung cancer and metastatic breast cancer, and now, the phase 2 DESTINY-PanTumo02 trial will help determine if it will be approved for patients with endometrial, cervical, ovarian, bladder, biliary tract, pancreatic or other cancers that are HER2 positive.

FDA Grants Fast Track Designation to Avutometinib-Lumakras Combo

Also in the regulatory space, the FDA granted a fast track designation to a two drug combination consisting of Lumakras and the novel agent, avutometinib for patients with KRAS G12C-mutant metastatic non-small cell lung cancer. The intended patient population for the regimen is those who have been treated with at least one systemic therapy and have not received a KRAS G12C inhibitor.

The regimen is being investigated in the ongoing phase 1/2 RAMP 203 trial, which will analyze the effectiveness of the drug, as well as the overall response rate — which is the percentage of patients whose cancer decreases from the drug — and safety. Findings from the second phase of the trial, which is specifically looking at patients who have not received or did not respond to a KRAS G12-inhibitor are expected to be published some time in the first half of 2024.

For more news on cancer updates, research and education, don’t forget to 

One cancer vaccine may still be years away from being available, a breast cancer test may be misguiding treatments for Black women and the review of two oncology regimens are being expedited by the FDA. 

FDA, Cancer Vaccine Updates and a Misguiding of Breast Cancer Treatment

It’s been a busy few weeks here at CURE® and in the oncology space as a whole, as the last two weekends had back-to-back meetings: the American Society of Clinical Oncology’s 

Here are some highlights from the conference, but as always, you can find all of our coverage at curetoday.com.

Imfinzi, Avastin, TACE May ‘Set a New Standard of Care’ in Liver Cancer

For patients with liver cancer whose disease is not eligible to be removed via surgery, adding Imfinzi and Avastin to transarterial chemoembolization — also known as TACE — tended to lengthen the time patients lived before their disease got worse, according to findings from the EMRALD-1 trial. These improvements in progression-free survival over TACE alone could lead to a new standard of care for this patient population, according to the lead study author, Dr. Riccardo Lencioni.

More specifically, patients who received Imfinzi and Avastin plus TACE lived for a median of 15 months before death or disease worsening, compared to 8.2 months for patients who received TACE alone. This correlates to a 23% reduction in the risk of disease progression or death, and benefits were seen across different patient subgroups.

Notably, the researchers on EMRALD-1 are still monitoring how the addition of the two drugs impacts overall survival. Once those data become more clear, it is possible that the drug manufacturers could submit this regimen to the FDA for approval, thereby officially shaking up the standard of care of TACE, which has remained the main treatment in this setting for about two decades.

Cancer in Bloodstream May Predict CRC Outcomes

Circulating tumor DNA — also known as ctDNA — was another hot topic at the Gastrointestinal Cancers Symposium. So ctDNA measures little fragments of cancer that are found in the bloodstream after cancer treatment.

Now, findings from the BESPOKE trial highlight the fact that ctDNA may offer insight into the recurrence risk in patients with stage 2/3 colorectal cancer who underwent surgery and then chemotherapy. The researchers used ctDNA to help determine minimal residual disease, or MRD, status. Essentially, patients with disease still detected in the blood stream were MRD positive, while those without detectable cancer were MRD negative. Findings showed that those with MRD negativity tended to live longer without experiencing relapse or death compared to patients with MRD positivity.

Survival Benefits with Keytruda and Padcev in Advanced Urothelial Cancer

Back in December, the Food and Drug Administration approved Padcev plus Keytruda for patients with previously treated locally advanced or metastatic bladder cancer. The approval was based on primary findings from the EV-302 trial. Now, updated findings from that trial are showing that the drug duo continues to outperform chemotherapy when it comes to progression-free survival — that’s the time patients live before their disease gets worse — as well as overall survival, which is the time patients live before death of any cause.

Notably, these survival benefits were seen across patient subgroups, such as those with visceral metastases and lymph node-only disease. According to the lead study author, Dr. Michiel S. Van Der Heijden, this could result in a new standard of care in patients with locally advanced or metastatic urothelial carcinoma.

Many Patients Miss Out on Testing to Guide Prostate Cancer Treatment

On the prostate cancer front, a study found that many people with metastatic castration-resistant prostate cancer are not undergoing germline or somatic testing. Now this is really important because back in 2020, two PARP inhibitors were approved in this setting. These are targeted drugs approved for patients whose cancers have certain characteristics, which can be determined by these types of tests.

Rates of germline and somatic testing have increased since the FDA approvals, but according to the study — which looked at real-world evidence of patients being treated in community cancer and urology centers — about 40% of patients did not undergo standard-of-care testing.

Study author, Dr. Neal Shore, said that this indicates the need for improved education on the importance of germline and somatic testing.

Here are some of the top stories from the recent Gastrointestinal Cancers Symposium as well as the Genitourinary Cancers Symposium. 

Highlights from the Gastrointestinal and Genitourinary Cancer Conferences 

Often, receiving a cancer diagnosis can require a crash course in oncology that few patients ever expected to take.

For colorectal cancer specialist Dr. Dustin Deming, a diagnosis of rectal cancer two weeks after receiving his first faculty appointment required an education of a different sort.

Deming is an ACI/Schwenn Family associate professor in the division of hematology, medical oncology and palliative care at UW School of Medicine and Public Health, and a gastrointestinal oncologist and laboratory researcher for UW Carbone Cancer Center.

During an interview with CURE®, he said he needed to learn how to be a patient.

“For me, the crash course was in being able to allow my medical friends to be my doctors,” said Deming. “So, that was the part that I really had to wrap my head around. I knew what we needed to do. I knew I knew what I was about to go through. But I hadn't sat in the patient chair before. And so, the crash course that I had to enter was the crash course in what it's like to be a patient.”

Deming was 31 at the time of his diagnosis in 2012, married and with a 12-week-old daughter who he’d brought to his colonoscopy appointment. Treatment with surgery, chemotherapy and radiation followed, with Deming working, as he was able to do so.

While colorectal cancer is the fourth most common cancer diagnosis in the United States, only 2% of new cases occur in patients ages 20 to 34, with the majority of cases (25.5%) occurring in patients ages 65 to 74, according to the National Cancer Institute.

“It’s obviously extremely ironic, and (was) potentially life-shattering at the time,” Deming said. “You know, when I was diagnosed, I had a 12-week-old daughter who came to the colonoscopy with me. Getting that kind of news at 31, I don't think anybody's prepared for. Having been a colon cancer doctor and researcher was helpful in that it provided me with insight into what we needed to do. But it was also terrifying, in that I knew all the dirty secrets.”

After being cancer-free for eight and a half years, Deming experienced a recurrence in 2020. He received further chemotherapy, radiation and surgery, followed by a second recurrence about a year later that was treated with surgery and chemotherapy. Approximately 10 months after his latest surgery, he has no evidence of cancer.

Dustin spoke with CURE’s “Cancer Horizons” podcast about his cancer journey, the connections it’s created with his patients and his continuing dedication to treating others.

“Having been a patient myself, I feel like — now, I don't know how it feels for each individual patient, but I know how it feels for me — I know how it feels to hear the ‘cancer’ word, I know how it feels to have to go through chemo, radiation and multiple surgeries,” Deming said. “So, every time I meet a patient for the first time, I sit down and tell the patients kind of where I've been so that they know where I'm coming from and also (to) make sure that they know that I now get it and that I'm actually truly honored to be part of the team helping take care of them.

“I know what it means to trust oncologists with your care, and I'm so glad that I'm here to be able to help more patients.”

University of Wisconsin Carbone Cancer Center

Dr. Dustin Deming, a gastrointestinal oncologist, began his own cancer journey more than a decade ago when he received a diagnosis of rectal cancer.

How a Cancer Journey Connects Oncologist to His Patients

This week in oncology news, we saw a few decisions from the Food and Drug Administration, ranging from the agency agreeing to review a drug and potentially grant it a full approval to their citing manufacturing concerns for a gastric cancer drug.

Additionally, a small study showed 100% disease control rate in a subtype of non-Hodgkin lymphoma, and a clinical evaluation of a new prostate cancer drug will continue to enroll patients.

FDA Accepts sBLA For Tivdak in Recurrent or Metastatic Cervical Cancer

The Food and Drug Administration has accepted a supplemental Biologics License Application (sBLA) to Tivdak for the treatment of patients with recurrent or metastatic cervical cancer that has progressed after first-line therapy. Tivdak, the first antibody-drug conjugate for this patient population, received accelerated approval in 2021. Now, the sBLA is for the continued approval, which is contingent upon clinical benefit verification in confirmatory trials.

Results from the phase 3 innovaTV 301 trial presented at the 2023 ESMO Congress demonstrated that Tivdak reduced the risk of death by 30% compared to chemotherapy as a second- or third-line treatment for this patient population. The trial also showed improvements in overall survival, progression-free survival, and confirmed objective response rate. Treatment-related side effects were observed in a majority of patients, with anemia and nausea being the most common.

The FDA plans on making a decision on the approval by May 9, 2024.

FDA Cites Manufacturing Concerns in Missed Gastric Cancer Drug Deadline

Also in FDA news from the week, the agency will not meet the Jan. 12, 2024, deadline for approving zolbetuximab, a drug designed for the treatment of unresectable or metastatic HER2-negative, CLDN 18.2-positive gastric or gastroesophageal junction adenocarcinoma.

The FDA attributed the delay to "unresolved deficiencies following its pre-license inspection of a third-party manufacturing facility" and issued a complete response letter to Astellas, clarifying that no clinical concerns, including safety and efficacy, were identified.

Zolbetuximab, a monoclonal antibody targeting the CLDN 18.2 protein overexpressed in certain gastric cancers, has shown promise in preclinical studies by inducing cell death in cancer cells. The drug had received a priority review from the FDA based on positive outcomes in the phase 3 SPOTLIGHT clinical trial and the GLOW clinical trial. Astellas, the manufacturer of the drug, is now collaborating with the FDA and the third-party manufacturer to address the identified issues and establish a timeline for resolving them.

Enrollment Continues in Study Evaluating ONCT-534 For Advanced Prostate Cancer

Patients are still being enrolled in an assessment of the novel drug, ONCT-534, for the treatment of advanced prostate cancer that has relapsed or is refractory to approved androgen receptor pathway inhibitors (ARPIs).

The study's first two cohorts received daily oral doses of 40 mg and 80 mg of ONCT-534, while the third and fourth patients, part of the third cohort, will be administered a 160 mg daily oral dose.

The ongoing phase 1/2 ONCT-534-101 study aims to determine the drug's safety, tolerability and preliminary antitumor activity, with a total of 27 patients in the first phase and two cohorts of 16 patients each in the second phase.

The study is anticipated to conclude in January 2028.

Novel Drug Shows 100% Disease Control Rate in WM

And finally, a novel drug, iopofosine I 131, showed a 100% disease control rate in patients with Waldenstrom’s macroglobulinemia, according to topline findings from the CLOVER WaM study.

The CLOVER WaM trial investigated iopofosine I 131 in 50 WM patients who had undergone at least two prior lines of therapy, including a BTK inhibitor. In an efficacy evaluable population of 41 patients who received a total dose of 60 mCi 60 or more days ago, the trial met its primary endpoint with a major response rate of 61%. The overall response rate in evaluable patients was 75.6%, with 100% experiencing disease control and 76% not experiencing disease progression at an average follow-up of eight months. Notably, 8% of patients achieved a stringent complete remission.

Now we should note, however, that this is a small study sample size of only 50 patients, so we would expect to see future studies evaluating this drug in a larger patient population.

Last week, the FDA provided updates on two cancer therapies. In this episode, we discuss those decisions and more. 

FDA Gives Cancer Drug Updates, Prostate Cancer Trial Enrolls Patients 

The year 2023 has come and gone, and we figured that now is the perfect time to look back on some of the top cancer-related stories from the year.

Vitamin D May Impact Colorectal Cancer Outcomes

In June, we spoke to an expert about research that analyzed 14 studies on vitamin D and colorectal cancer outcomes. Findings showed that people who had a vitamin D deficiency tended to have poorer mortality outcomes than those who supplemented with vitamin D.

Laura Bolte, of the department of gastroenterology and hepatology at the University of Groningen and University Medical Center Groningen, explained that the use of corticosteroids and being underweight or malnourished — which are all things that can happen during cancer treatment — can increase the risk of vitamin D deficiency, so it is essential that patients speak with their health care team to determine if a vitamin D supplement will be appropriate and beneficial to them.

Every now and then, major celebrity news makes cancer headlines. On Sept. 1, “Margaritaville” singer, Jimmy Buffett died of cancer at the age of 76.

Buffett had a rare and aggressive type of skin cancer called Merkel cell carcinoma, which is much more common to spread to other parts of the body, and can be very difficult to treat if it spreads, according to the American Cancer Society.

Shortly after Buffett’s death, we spoke to Dr. Manisha Thakuria, who is the director or Merkel cell carcinoma at the Dana-Farber Cancer Institute. She said, “It's always hard to see any silver linings in losses. I am glad to see Merkel cell having a little bit of a spotlight on it, and I hope that (the media interest) will increase research funding for Merkel cell carcinoma and help more patients,” said Thakuria.

Chemo Drug Shortage Requires a ‘Holistic Solution’

Perhaps one of the biggest headlines in the cancer space from 2023 was the chemotherapy shortage. The shortage of cisplatin and carboplatin required a “holistic solution,” according to Dr. Anjan J. Patel.

In a June article, I spoke with Dr. Patel and other oncology experts about the shortage, what it meant for patients taking these drugs and what was needed from a systemic level to ensure that these types of shortages never happened again.

Patients Using Cannabis Experienced Worse Symptoms, Perceive Less Harm

Patients with cancer who use cannabis reported more severe symptoms and perceived less potential harm from cannabis than patients with cancer who did not use the drug within the last 30 days, according to study findings published this summer.

From Jimmy Buffett's death to the chemo shortage and cannabis use in cancer care, here is a look back at some of our most popular oncology stories from 2023. 

Gastrointestinal Cancers

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