Search Results for “cancer” – Page 107 – media

Darzalex Faspro in Multiple Myeloma, Imbruvica-Venclexta in Mantle Cell Lymphoma

By Tristan Manalac Ahead of the 65th Annual Meeting and Exposition of the American Society of Hematology, taking place Dec. 9 to 12, event organizers on Tuesday released late-breaking abstracts providing an early view of some of the most high-impact studies in blood disorders to be presented at the conference. Focus on two of those studies below. J&J, Genmab’s Darzalex Faspro Early data from the Phase III PERSEUS study showed that J&J and Genmab’s subcutaneous anti-CD38 antibody Darzalex Faspro (daratumumab and hyaluronidase-fihj) significantly prolonged progression-free survival (PFS) in patients with newly diagnosed multiple myeloma (NDMM). PERSEUS enrolled 709 patients in total, of whom 355 were randomly assigned to receive Darzalex Faspro combined with bortezomib, lenalidomide and dexamethasone (VRd). At a median follow-up of 47.5 months, patients treated with the Darzalex Faspro regimen saw a significantly better PFS versus comparators who received VRd alone. The effect had a hazard ratio of ...
- Source: drugdu
- 114
- November 25, 2023
Boehringer Ingelheim to acquire T3 Pharmaceuticals in deal worth over $500m

Boehringer Ingelheim has said it will be acquiring bacterial cancer therapy specialist T3 Pharmaceuticals in a deal worth over $500m, marking a significant boost to its immuno-oncology portfolio. Boehringer said it is seeking to “significantly increase” the current 15 to 20% remission rate in cancer patients by utilising complementary immuno-oncology platforms such as T-cell engagers, oncolytic viruses and cancer vaccines. T3, founded in 2015 as a spinout from the University of Basel in Switzerland, has developed a proprietary therapy platform that uses live bacteria to deliver immune-modulating proteins directly to cancer cells and tumour micro-environments while sparing healthy tissues. The bacteria can be loaded with multiple immune-modulatory proteins of choice, allowing the design of immuno-oncology combination therapies in one single agent. Michel Pairet, member of the board of managing directors at Boehringer with responsibility for the Innovation Unit, said: “The acquisition of T3 Pharma will significantly expand our immuno-oncology pipeline ...
- Source: drugdu
- 104
- November 25, 2023
Investigating Industry Involvement in Modern Clinical Trials

Don Tracy, Associate Editor Study aims to find ways industry gets involved in the most influential clinical trials, and how transparent these trials are. In a study published earlier this month by JAMA, the authors aimed to discover how the pharmaceutical industry gets involved in the most influential modern clinical trials and how they fare in terms of transparency. Crediting the major impact of these clinical trials on medical practice, the authors believed that it was important to evaluate the extent of industry involvement and the use of transparency practices in such studies published in the last few years. In order to find a sufficient answer, the study relied on a meta-research assessment consisting of 600 randomized and nonrandomized clinical trials published in 2019 or later. Trials that attracted the highest number of number of citations in Scopus as of December 2022 were selected for analysis, occurring from March to ...
- Source: drugdu
- 107
- November 24, 2023
Why 1 Health System Is Embedding Genomics Into Primary Care

When people think of genomics, they typically don’t visualize the primary care setting — but Northshore–Edward Elmhurst Health is trying to change that. Genomics is a key part of the health system’s approach to personalized care delivery, said Kristen Murtos, its chief innovation and transformation officer, in a recent interview. NS-EEH, the third largest health system in Illinois, was created in January 2022 when NorthShore University HealthSystem and Edward-Elmhurst Health completed their merger. “Several years ago, NorthShore leaned heavily into the power of genomics and integrated that as part of primary care practice — unlocking the opportunity to more holistically understand predisposition to certain diseases, to tailor care plans and to be able to give proactive and preventative care versus waiting until disease manifests and just being treated after that,” she explained. At NS-EEH, all patients are offered genetic testing as part of their primary care visit, Murtos pointed out. ...
- Source: drugdu
- 105
- November 23, 2023
Bayer’s trial flop, courtroom setback could restrict CEO’s options amid strategic review

After suffering setbacks in the clinic and in court over the last week, Bayer’s ability to overhaul its corporate structure is becoming more constricted, one group of analysts contends. Still, the German conglomerate is trying to keep its head up as it presses on with a strategic review under new CEO Bill Anderson. Bayer’s very bad week started with the failure of its potential blockbuster-in-waiting asundexian to top Bristol Myers Squibb and Pfizer’s Eliquis in a phase 3 trial. In light of the blood thinner’s inferior efficacy, Bayer elected to stop the study early while continuing to advance the asset in stroke. Bayer is counting on new drugs like asundexian to offset the upcoming loss of exclusivity on its Johnson & Johnson-partnered med Xarelto. Separately, a Missouri jury on Monday ordered Bayer to shell out $1.56 billion to four plaintiffs over claims the company’s Roundup weedkiller caused their cancer. Bayer ...
- Source: drugdu
- 93
- November 23, 2023
China’s NMPA grants conditional approval for Apollomics’ NSCLC drug

The National Medical Products Administration (NMPA) of China granted conditional approval to biotech Apollomics for the commercialisation of its non-small cell lung cancer (NSCLC) treatment. Velbretinib (APL-101) is an orally bioavailable small molecule that treats NSCLC patients with MET exon 14 skipping alterations by inhibiting c-Met. This is a protein that is key in the tumour growth pathway. MET exon 14 skipping mutations occur in approximately 3% of cases of NSCLC. This condition is most diagnosed in adults aged over 70 with a smoking history. China’s NMPA grants conditional approvals to treatments for diseases that are severely life-threatening and there is no effective treatment method. Under the terms of an agreement, the company’s Chinese partner, Avistone, holds the drug’s exclusive rights in China, Hong Kong and Macau. Apollomics holds the rights for the US and all other countries. California-headquartered Apollomics is also in active discussions with the US Food and ...
- Source: drugdu
- 103
- November 21, 2023
FDA signs off on new uses for Astellas and Pfizer’s Xtandi, Merck’s Keytruda

The FDA has signed off on label expansions for two of the world’s most important cancer medicines—Merck’s Keytruda and Pfizer and Astellas’ Xtandi. Keytruda’s expansion is in stomach cancer, allowing its use alongside chemotherapy to treat first-line patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma. Xtandi’s new indication expands its already deep portfolio in the treatment of prostate cancer. It now becomes the only androgen receptor inhibitor approved by the FDA for patients with nonmetastatic castration-sensitive prostate cancer (nmCSPC) with biochemical recurrence at high risk for metastasis (high-risk BCR). These patients can be treated with Xtandi with or without GnRH analog therapy. Of men who have had prostate cancer treatment, 20% to 40% will have BCR within 10 years. Of those with high-risk BCR, 90% will develop metastatic disease, with one in three dying. The nod was backed up by the phase 3 EMBARK ...
- Source: drugdu
- 111
- November 21, 2023
BMS strengthens NSCLC market share with ROS1 drug Augtyro

The US Food and Drug Administration (FDA) has approved Bristol Myer Squibs’ (BMS) Augtyro (repotrectinib) for adults with non-small cell lung cancer (NSCLC). Augtyro is an orally administered tyrosine kinase inhibitor (TKI) designed to selectively bind to active kinase formations in ROS1-positive NSCLC and suppress uncontrolled cell proliferation and tumor growth caused by ROS1 oncogenic fusions. It is the only FDA-approved TKI for ROS1-positive NSCLC. The FDA approval was based on data from the ongoing Phase I/II TRIDENT-1 (NCT03093116) trial, which is evaluating repotrectinib in 500 patients with advanced solid tumours characterized by ALK, ROS1, or NTRK1-3 fusions. The Phase I portion assessed the safety, tolerability, and pharmacokinetics of repotrectinib. Patients previously treated with a TKI and no chemotherapy demonstrated an overall response rate (ORR) of 38% and a median DOR of 14.8 months. Patients with no prior treatment with a TKI had an ORR of 79% and a median ...
- Source: drugdu
- 97
- November 20, 2023
BMS Drug Augtyro Gets FDA Approval to Treat ROS1-Positive NSCLC

By Tyler Patchen The FDA has approved Bristol Myers Squibb’s tyrosine kinase inhibitor Augtyro (repotrectinib) to treat patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer, augmenting the company’s arsenal of cancer and NSCLC treatments. According to BMS’s Wednesday announcement, the drug is meant to “minimize interaction” that can lead to certain forms of treatment resistance in ROS1-positive NSCLC patients. The FDA approved the drug based on the TRIDENT-1 study evaluating Augtyro in TKI-naïve and TKI-penetrated patients. Results showed that for TKI-naïve individuals, the objective response rate (ORR) was 79%, with a median duration of response of 34.1 months. For patients that were TKI-penetrated and had no chemotherapy, the ORR was 38%, with a median duration of response of 14.8 months. “New treatment options continue to be needed for patients with ROS1 fusion-positive NSCLC that support important clinical goals, including achieving durable therapeutic responses,” Jessica J. Lin, the ...
- Source: drugdu
- 182
- November 18, 2023
IO Biotech enrols 380 patients with advanced melanoma in phase 3 trial

The trial is evaluating an investigational cancer vaccine in combination with KeytrudaIO Biotech has announced that it has completed the enrolment of 380 patients in a phase 3 clinical trial of its investigational immune-modulating therapeutic cancer vaccine in advanced melanoma. The open-label, randomised clinical study being conducted in collaboration with Merck & Co – known as MSD outside the US and Canada – is comparing the candidate IO102-IO103 in combination with Merck’s anti-PD-1 therapy Keytruda (pembrolizumab) versus Keytruda alone in patients with previously untreated, unresectable or metastatic melanoma. The cancer vaccine in combination with a PD-1 inhibitor has already demonstrated “approximately double the effect than would have been expected with PD-1 inhibitor monotherapy in this patient population,” said Mai-Britt Zocca, president and chief executive officer of IO Biotech, with results from a phase 1/2 study showing that 80% of patients achieved a response and 50% achieved a complete response. Furthermore, ...
- Source: drugdu
- 103
- November 17, 2023

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