Astrazeneca Plc /Anti Infective Business/

Merck announced Thursday that its investigational antibody treatment, clesrovimab, demonstrated a 60.4 percent effectiveness in reducing infections associated with a specific type of respiratory syncytial virus (RSV) in infants. This seasonal injection regimen successfully achieved its primary goal in the mid to late phase of the trial, significantly reducing the incidence of medically care-required lower respiratory tract infections due to RSV in healthy infants under 1 year of age during the first RSV season. Merck further noted that clesrovimab also significantly reduced RSV-related hospitalizations by as much as 84.2% compared to placebo. The rate of side effects caused by the drug during treatment was comparable to that of the placebo group, and there were no deaths directly related to treatment or RSV during the study period. Merck previously announced in July that the vaccine had met the main goal of the study, but did not disclose details at the time. If approved, clesrovimab will compete in the U.S. market with Sanofi's (SASY.PA) and Astrazeneca's (AZN.L) Beyfortus, also an antibody therapy that prevents RSV infections in infants and children and requires a quarterly injection. In a separate late-stage study, Beyfortus was able to reduce the incidence of lower respiratory infections in infants requiring medical care by 74.5%. In addition, Synagis from Swedish orphan drug company Biovitrum (SOBIV.ST) is available as a treatment to prevent RSV, requiring monthly injections. Merck reported on Thursday that clesrovimab was on par with Synagis in terms of safety, a conclusion based on interim results from another late-stage study. Notably, Pfizer's RSV vaccine Abrysvo is already approved for use in pregnant women and is designed to prevent RSV infection in babies during the first six months of life. RSV often causes cold-like symptoms and is one of the leading causes of pneumonia and death in infants and the elderly. In the United States, the virus causes about 177,000 hospitalizations and 14,000 deaths each year.

As Roche faces increasing market competition in its breast cancer treatments, the company is eager for its new drug to breathe new life into its once-stellar portfolio and generate up to 2 billion Swiss francs in additional revenue. The drug, called inavolisib, has been approved by the U.S. Food and Drug Administration (FDA) and is designated to treat HR-positive, HER2-negative breast cancer patients with PIK3CA mutations who have developed resistance to adjuvant endocrine therapy. As an oral drug, inavolisib will be used in combination with Pfizer's Ibrance and Astrazeneca's Faslodex in hopes of achieving better therapeutic outcomes. Roche plans to market inavolisib under the brand name Itovebi, which will compete directly with Novartis' PI3K inhibitor Piqray and Astrazeneca's AKT inhibitor Truqap. Despite the fierce competition in the market, Roche executive Teresa Graham remains confident about Itovebi's market prospects, predicting peak sales of 2 billion Swiss francs ($2.3 billion). During an investor call in April, Graham presented this sales forecast, explaining that PIK3CA mutations occur in about 40 percent of HR-positive breast cancer patients and that she believes inavolisib is a more effective drug than Piqray. Charlie Fuchs, MD, head of global product development for oncology and hematology at Roche subsidiary Genentech, noted in an interview with Fierce Pharma that while the existence of the PIK3CA mutation has been known for decades, But surprisingly, it has been difficult to treat because many of the drugs that have been developed have limited efficacy and are poorly tolerated. Dr. Fuchs emphasized that Itovebi has the best potential in its class from both a efficacy and safety perspective. The drug has strong data to support its efficacy. In the Phase 3 INAVO120 trial, adding Itovebi to the regimen of Ibrance and Faslodex significantly reduced the risk of disease progression or death by 57 percent. Patients in the Itovebi group had disease without progression for an average of 15 months, compared with 7.3 months in the control group. The study specifically enrolled patients with tumors with PIK3CA mutations that rapidly progressed after postoperative endocrine therapy and were thought to be resistant to endocrine therapy.

Astrazeneca announced the results of an impressive clinical trial on September 23, 2024, in the TROPION-Breast01 Phase III trial of its experimental precision drug Dato-DXd, developed with Daiichi Sankyo of Japan, against a type of breast cancer. There was no significant improvement in overall survival (OS), which was not statistically significant. This news not only caused widespread concern in the industry, but also caused investors to re-evaluate the future market prospects of the drug. The TROPION-Breast01 Phase III trial was designed to evaluate the efficacy and safety of Dato-DXd in a specific population of breast cancer patients. Although Dato-DXd is an innovative antibody drug conjugate (ADC) designed to combine a monoclonal antibody that can accurately identify tumor cells with a highly effective cell-killing chemotherapy drug to achieve more precise targeted therapy and higher therapeutic efficacy, the improvement in overall survival in this trial did not achieve the expected statistical difference. Susan Galbraith, executive vice president of Oncology Research and Development at Astrazeneca, said: "We are disappointed with this result, but the road to scientific exploration is always challenging. We will continue to engage closely with regulators, analyze the trial data in depth, and apply these valuable lessons and insights to our future datopotamab deruxtecan clinical development program for breast cancer." Her words reveal a determined and indomitable spirit, demonstrating Astrazeneca's professionalism and responsibility in drug discovery. Notably, Dato-DXd has previously achieved encouraging results in another study in advanced breast cancer, successfully meeting the primary goal of progression-free survival (PFS). This achievement not only demonstrates the potential efficacy of the drug in a specific patient population, but also lays a solid foundation for subsequent clinical trials and drug development. However, the failure of this TROPION Breast01 Phase III trial has undoubtedly cast a shadow over the future development of the drug. Ken Takeshita, Global Head of Research and Development at Daiichi Sankyo, added: "We understand that this result is an important moment for patients, investors and the industry as a whole. But please be assured that we remain confident in datopotamab deruxtecan and are committed to building it as another potential treatment option for patients." We will continue to further study the mechanism and action of this drug, with a view to achieving more significant efficacy in the future." In addition, the failure of this trial has triggered a wide discussion in the industry about the efficacy and suitability of ADC drugs. Some experts pointed out that although ADCs have the advantages of precise targeting and efficient killing in theory, they still face many challenges and uncertainties in practical application. Therefore, future drug development needs to pay more attention to the in-depth understanding of the mechanism of drug action and the precise screening of patient groups, in order to achieve more accurate and effective treatment. The failure of Dato-DXd, which Astrazeneca developed in collaboration with Daiichi Sankyo, in the TROPION-Breast01 Phase III trial has undoubtedly created some uncertainty about the future development of the drug. However, we believe that with the unremitting efforts and continuous exploration of both parties, this drug is expected to bring more Gospel and hope to patients in the future. At the same time, we also expect the industry to continue to strengthen the research and development of ADC drugs, to bring more innovation and breakthroughs in the field of cancer therapy.