Pharmaceutical Executive Editorial Staff Phase III trial to investigate novel individualized neoantigen therapy V940 (mRNA-4157) in combination with Keytruda (pembrolizumab) as an adjuvant treatment for patients with completely resected Stage II, IIIA, or IIIB non-small cell lung cancer. Image credit: Axel Kock | stock.adobe.com Merck and Moderna, Inc., have announced plans to launch the pivotal Phase III INTerpath-002 (NCT06077760) clinical trial of the novel individualized neoantigen therapy V940 (mRNA-4157) in combination with Keytruda (pembrolizumab) as an adjuvant treatment for patients with completely resected Stage II, IIIA, or IIIB non-small cell lung cancer (NSCLC). V940 is comprised of synthetic mRNA coding for up to 34 neoantigens that are designed and produced based on the unique mutational signature of a patient’s tumor. After administration of the drug, the algorithmically derived and RNA-encoded neoantigen sequences are endogenously translated and undergo natural cellular antigen processing and presentation. “As lung cancer is the leading cause ...
The most common type of breast cancer now has a new targeted treatment: an AstraZeneca drug that’s first in a new class of therapies addressing a certain genetic signature. But the new approval is narrower than expected, which limits the total addressable market for the therapy. The FDA approved the new drug, capivastertib, for use in combination with fulvestrant, an older AstraZeneca breast cancer therapy. The new drug will be marketed under the brand name Truqap. Approval of Truqap covers the treatment of adults with advanced cases of breast cancer classified as HR positive and HER2 negative. Those patients must also have disease that has either progressed after treatment with a hormone therapy or has come back after adjuvant therapy. Truqap joins a group of therapies already available for HR positive, HER2 negative breast cancer, including products from AstraZeneca. Truqap stands apart from them as the first AKT inhibitor. AKT ...
Roche has announced that an injectable form of its PD-L1 inhibitor Tecentriq (atezolizumab) has been recommended by the European Medicines Agency’s human medicines committee for multiple cancer types. The subcutaneous (SC) formulation of Tecentriq can cut treatment time by approximately 80%, the company said, with most injections taking between four to eight minutes compared with 30 to 60 minutes for an intravenous (IV) infusion. The Committee for Medicinal Products for Human Use (CHMP) has specifically recommended that Tecentriq SC be authorised for use in all indications in which the drug’s IV form has previously been approved, including certain types of lung, liver, bladder and breast cancer. The committee’s decision will now be reviewed by the European Commission and, if approved, Tecentriq SC will be the first injectable PD-L1 cancer immunotherapy in the EU. Levi Garraway, Roche’s chief medical officer and head of global product development, said: “Tecentriq has helped to ...
Up until this point, immune checkpoint inhibitors have been allowed to treat early-stage non-small cell lung cancer (NSCLC) either before or after surgery. Thanks to a new FDA approval, a continuous immunotherapy regimen for use on both sides of surgery is now available for certain patients. The approval, for Merck’s Keytruda, clears the PD-1 inhibitor to be used both as part of a neoadjuvant regimen before surgery and as an adjuvant therapy after surgery in patients with resectable NSCLC. Patients also take chemotherapy during presurgical treatment. In a coveted win for Merck, Keytruda’s updated label (PDF) already includes data showing that, compared with neoadjuvant chemo alone, the addition of perioperative Keytruda significantly cut the risk of death by 28% in the Keynote-671 study. Patients who took neoadjuvant chemo alone lived a median 52.4 months, while the median result for the Keytruda arm wasn’t reached by the time of the analysis, ...
In a recent study published in the journal Environmental Health Perspectives, researchers have found that women living in neighborhoods characterized as walkable, based on factors like population density and accessibility to destinations, have a reduced risk of obesity-related cancers, including postmenopausal breast cancer, as well as multiple myeloma, ovarian, and endometrial cancers. Background Obesity is a growing health concern, with over 40% of adults in the United States being obese or overweight. This condition also significantly increases the risk of various cancers, particularly among women. About 55% of diagnosed cancers in women are linked to obesity, while the figure is approximately 24% for men. Inactivity among women is believed to further exacerbate the risk of obesity-related cancers. Increasing evidence highlights walking as a moderate-intensity physical activity that contributes significantly to recommended exercise levels for maintaining good health. Recent research has focused on how the built environment affects physical activity and, ...
Around 340,000 to 444,000 people in the UK carry one of nine pathogenic gene variants The National Institute for Health and Care Excellence (NICE) has recommended that more people get tested for genes linked to ovarian cancer. The new guideline aims to raise awareness and increase the availability of genetic testing, allowing people to take preventive measures, including surgery, to prevent the development of ovarian cancer. Anyone can carry a gene linked to ovarian cancer, including women, men, transgender people, and non-binary people, which can be passed on to their children. In the UK, around 340,000 to 440,000 people carry one of the nine pathogenic variants – BRCA1, BRCA2, MLH1, MSH2, MSH6, RAD51C, RAD51D, BRIP1 and PALB2 – that cause cancer, 3% of whom know they have a high-risk gene. NICE has recommended that genetic services should test and assess the likelihood of people carrying the genes, including those who ...
Photo: Kiyoshi Ota/Bloomberg, via Getty Images Astellas Pharma is far from alone in viewing cancer as a major growth area, but the Japanese drugmaker has specifically identified a type of therapy called targeted protein degradation as one of the key areas for increasing revenue. It just struck its second deal in the past two months to help it execute on that strategy and perhaps stand apart from others pursuing the same type of drugs. Under a partnership announced Tuesday, Astellas will work with PeptiDream to discover new protein degraders using the technology of that company. Specific targets were not disclosed, but they will be selected by Astellas. The deal also grants Tokyo-based Astellas the option to select up to three additional targets for inclusion in the collaboration. Astellas will pay PeptiDream 3 billion yen (about $21 million) up front. PeptiDream, based in Kawasaki, Japan, is eligible to receive up to ...
Two cancers studies are slated to grab significant attention at the upcoming American Society of Clinical Oncology 2023 annual meeting, and each could lead to a major label expansion for the companies involved. With KEYNOTE-671, Merck is looking to shake up how nonmetastatic non-small cell lung cancer (NSCLC) is treated by testing Keytruda both before and after surgery. For its part, Novartis will elaborate on the postsurgery data for Kisqali in early breast cancer from the NATALEE trial. When the company said the trial met its endpoint, investors sent the Big Pharma’s stock price up by 8% in a single day. Before the official data revelations on June 2 for NATALEE and June 3 for KEYNOTE-671, Fierce Pharma gathered expectations for the two studies from oncology leaders at Penn Medicine and MD Anderson Cancer Center plus market analysts at multiple firms. The NATALEE study could open a market that’s worth ...
Eli Lilly is throwing more money behind breast cancer drug Verzenio as it prepares to fend off a challenge from Novartis. Having seen growth hit 100% late last year, the Big Pharma has released a TV spot to push the message that Verzenio can help patients make new memories every day. Ads for Verzenio are a frequent sight on TV screens, with the estimated $111.8 million that Lilly spent on spots last year landing the drug in the 10 top most promoted products. Lilly has continued the promotional push in 2023. The “School Play” Verzenio spot was the second most seen pharma TV ad at the 65th Annual Grammy Awards early this year, and Lilly rolled out a fresh video earlier this month. The latest ad opens with a gray-haired Black woman sitting on a sofa looking at a photo album. As the camera zooms in and flips to an over-the-shoulder shot, a voice-over by the woman says ...
Quest Diagnostics is boosting its capabilities in cancer, paying $300 million to acquire a Johns Hopkins University spinout whose technology identifies cancer cells in order to guide treatment decisions. The Secaucus, New Jersey-based diagnostics giant on Thursday announced the cash acquisition of Haystack Oncology. The Baltimore-based startup is part of a growing area in cancer testing called liquid biopsies, tests that detect cancer by finding circulating tumor DNA in a patient’s blood sample. Grail and Guardant Health are among the companies that market tests that detect early signs of cancer, enabling clinicians to intervene sooner. Haystack’s focus is minimal residual disease—detecting cancer cells that remain following initial treatment with surgery or a drug. Test results help clinicians assess how well the initial treatment worked and whether additional treatment, called an adjuvant, is necessary to kill any lingering cancer cells. That’s important because additional treatment, often a chemotherapy, introduces a wide ...
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