High-level overall survival (OS) results from the TROPION-Lung01 Phase III trial, which previously met the dual primary endpoint of progression-free survival (PFS), numerically favoured datopotamab deruxtecan (Dato-DXd) compared to docetaxel in the overall trial population of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) treated with at least one prior line of therapy. Survival results did not reach statistical significance in the overall trial population. In the prespecified subgroup of patients with nonsquamous NSCLC, datopotamab deruxtecan showed a clinically meaningful improvement in OS compared to docetaxel, the current standard-of-care chemotherapy. The final analysis of OS builds on the positive progression-free survival (PFS) results presented at the 2023 European Society for Medical Oncology Congress which showed datopotamab deruxtecan demonstrated a statistically significant improvement in PFS in the overall trial population and a clinically meaningful PFS benefit in patients with nonsquamous NSCLC. In TROPION-Lung01, patient enrolment by tumour histology ...
Roche is looking to share in the windfall from the sales in obesity therapies as it announces positive results from the Phase Ib trial of its investigational obesity and type 2 diabetes (T2D) therapy. CT-388 is a once-weekly subcutaneous dual glucagon-like peptide 1 (GLP-1) and gastric inhibitory polypeptide (GIP) receptor agonist. It selectively targets two incretin receptors that control food intake, energy absorption and assimilation. The therapy has a similar mechanism of action as Eli Lilly’s Mounjaro (tirzepatide), which generated $1.81bn in sales in Q1 this year, according to Lilly’s financials. Following today’s news, the Swiss company’s share was up by over 3.5% in trading today on the Swiss stock market. Roche’s market cap is SFr190.6bn ($210.8bn). The placebo-controlled Phase Ib trial (NCT04838405) enrolled approximately 96 overweight or obese participants with or without T2D. The participants in the CT-388 group achieved a mean placebo-adjusted weight loss of 18.8% at 24 ...
Blackstone Life Sciences startup Uniquity Bio emerged from stealth with an in-licensed drug candidate that could treat a wide range of immunology and inflammation indications. The antibody’s target puts it in competition with drugs from AstraZeneca, Pfizer, and Sanofi.Immunology and inflammation continues to be one of the hottest areas for research, and investment firm Blackstone is joining in with the launch of Uniquity Bio, a new startup whose lead asset from Merck addresses a clinically validated target that puts it in direct competition with some big pharmaceutical companies. Uniquity is backed by up to $300 million in financing from Blackstone Life Sciences, the firm’s biotechnology investment division. The in-licensed Merck drug, solrikitug, is ready to begin Phase 2 development in its lead indications, chronic obstructive pulmonary disease (COPD) and asthma. The Uniquity pipeline includes a third undisclosed gastrointestinal indication. Solrikitug is a monoclonal antibody designed to block thymic stromal lymphoprotein ...
The flurry of Trodelvy developments accentuates what Gilead CEO Dan O’Day called “a time of focused execution” at the California biotech. (Jim Watson/AFP/Getty Images) After a negative phase 3 readout, Gilead Sciences is taking a $2.4 billion impairment charge on Trodelvy, which serves as the cornerstone of the company’s solid tumor ambition. Gilead has cut the carrying value of Trodelvy to $3.5 billion in its first-quarter report, from $5.9 billion at the end of 2023, CFO Andrew Dickinson told investors during a call Thursday. The move comes after a January report of a phase 3 trial that the TROP2-directed antibody-drug conjugate failed to significantly extend the lives of patients with previously treated non-small cell lung cancer compared with chemotherapy. The bad news at that time caused a 10% slide in Gilead’s stock price. The write-off reflects a “smaller addressable market that Trodelvy could serve among second-line-plus metastatic non-small cell lung ...
Pfizer will offer a warranty program for its first FDA-approved gene therapy. The hemophilia B treatment will go for $3.5M, matching the price tag on CSL and uniQure’s hemophilia B gene therapy Hemgenix. (Pfizer) Ten years after dipping its toes into the gene therapy pool in a licensing deal with Spark Therapeutics, Pfizer has gained FDA approval for the acquired treatment. The U.S. regulator has endorsed Beqvez (fidanacogene elaparvovec-dzkt) for adults with the bleeding disorder hemophilia B. It becomes the first FDA-approved gene therapy for Pfizer and the second in the indication following CSL and uniQure’s hemophilia B treatment Hemgenix, which became the world’s most expensive drug at $3.5 million when it was approved in 2022. Pfizer had the chance to undercut its rival on price but decided to charge the same $3.5 million for Beqvez. The therapy will be available to patients this quarter, a spokesperson confirmed on Friday ...
Davy James The approval of AstraZeneca’s and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) for adults with unresectable or metastatic HER2-positive solid tumors adds to the drug’s approved indications in breast cancer, non-small cell lung cancer, and gastroesophageal junction adenocarcinoma. The FDA has granted accelerated approval to AstraZeneca’s and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) for adults with unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-positive, immunohistochemistry (IHC) 3+ solid tumors who were previously administered systemic therapy and who have no satisfactory alternative treatment options.1 The regulatory action for the HER2-directed antibody-drug conjugate (ADC) adds to Enhertu’s approved indications in breast cancer, non-small cell lung cancer (NSCLC), and gastroesophageal junction adenocarcinoma. “As the first antibody drug conjugate to be granted a tumor-agnostic indication, Enhertu is truly delivering on its potential across metastatic HER2-targetable tumors,” said Dave Fredrickson, executive vice president, Oncology Business Unit, AstraZeneca, in a press release. “This approval also ...
Don Tracy, Associate Editor Treatment approved in combination with ravulizumab or eculizumab, representing minority demographic still suffering after receiving C5 inhibitor therapy for extravascular haemolysis. Alexion, AstraZeneca Rare Disease announced that the FDA has approved Voydeya (danicopan) as an add-on therapy for the treatment of extravascular haemolysis (EVH) in adults with paroxysmal nocturnal hemoglobinuria (PNH), in combination with ravulizumab or eculizumab. According to the company, the medication treats patients with significant EVH despite receiving C5 inhibitor therapy. The approval was based on positive results from the Phase III ALPHA trial, which found that Voydeya improved hemoglobin levels while providing the benefit of avoiding transfusions after a primary 12-week period. Additionally, there was no significant increases reported related to safety concerns, with common adverse reactions including headache, nausea, arthralgia, and diarrhea.1 “The approval of first-in-class, Factor D inhibitor Voydeya marks an important advancement in the treatment of PNH and builds on ...
Alexion, AstraZeneca Rare Disease has received approval from the US Food and Drug Administration (FDA) for Voydeya (danicopan) as an add-on therapy to treat extravascular haemolysis (EVH) in adults with paroxysmal nocturnal haemoglobinuria (PNH). A first-in-class, oral Factor D inhibitor, Voydeya has been developed for patients who continue to suffer from EVH despite treatment with C5 inhibitors such as Ultomiris (ravulizumab) or Soliris (eculizumab). The FDA’s decision is grounded in the positive outcomes of the ALPHA Phase III trial, which demonstrated that Voydeya met its primary endpoint of haemoglobin change from baseline to week 12, alongside all key secondary endpoints. The drug was generally well-tolerated with no new safety concerns. As part of the ALPHA double-blind, placebo-controlled, multiple-dose trial, patients were enrolled and randomised to receive Voydeya or placebo apart from their ongoing Soliris or Ultomiris therapy over 12 weeks. It aimed to assess the superiority of Voydeya as an ...
On the afternoon of March 29, the Boao Forum for Asia (BFA) 2024 Annual Conference came to an end. During the four-day conference, nearly 2,000 Chinese and foreign guests from more than 60 countries and regions focused on the theme of “Asia and the World: Common Challenges, Common Responsibilities”, exchanged views on the world economy, scientific and technological innovation, social development, international cooperation and other issues, and discussed the propositions of the times together. Dr. Xuefeng Yu, Chairman and CEO of CanSinoBio, was invited to attend the forum and discussed with more than 20 medical and health experts, industry think tanks and representatives of innovative enterprises from China, the United Arab Emirates, Kenya, Nigeria, South Africa, Singapore, and India on the theme of “Health without Borders – International Medical and Healthcare Cooperation. Through the development of new quality productivity, strengthen the global cooperation to eliminate health disparities and promote global ...
The European Medicine’s Agency (EMA) has granted priority medicines (PRIME) status to 89bio’s pegozafermin, a drug being evaluated to treat patients with non-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH) with advanced forms of fibrosis. The EMA’s PRIME scheme is designed to expedite the development of medicines that meet an unmet need, such as rare diseases. The agency upgraded the scheme last year to enhance scientific advice and regulatory package preparation for sponsors of the scheme. 89bio’s pegozafermin was granted PRIME status based on positive data from the company’s Phase IIb ELIVEN trial (NCT04929483), according to a 27 March press release. The randomised trial saw three doses of the drug administered either once weekly or biweekly in 192 patients with non-cirrhotic MASH with fibrosis (F2-F3) and MASH with compensated cirrhosis (F4). Patients in the biweekly 44mg and once-weekly 30mg treatment groups saw significant one-stage fibrosis improvement without MASH worsening. MASH resolution without worsening ...
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