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We've had Eyes On some of the latest data, commercial strategies, and FDA updates. What caught your eye last week?
Pfizer revealed its oncology business plan during the recent ASCO 2024 meeting in Chicago. The company aims to have eight blockbuster cancer drugs by as early as 2030, coming from its focused therapeutic areas of hematology, thoracic, breast, and genitourinary cancers. Following the reworking of Pfizer’s commercial infrastructure in which oncology became a separate division, accommodating the $43 billion acquisition Seagen (antibody-drug conjugate specialist) tie-up deal, the company is at the scale ‘it needs to be’ (according to Suneet Varma). The newly merged Oncology Commercial and Medical team will utilize Pfizer’s publicist and digital tools to enhance Seagen’s products, such as the Astellas-partnered bladder cancer drug Padcev.
Also, during the recent ASCO meeting, Pfizer released updated phase 3 results for the ALK inhibitor Lorbrena in newly diagnosed advanced ALK-positive non-small cell lung cancer. Results show that 60% of patients who were given Lorbrena in the CROWN trial stayed alive without disease progression, as opposed to only 8% of patients who received Pfizer’s old ALK drug Xalkori. Lorbrena also caused a 94% reduction in the progression of brain metastases or an 81% reduction in the risk of disease progression or death compared to Xalkori.
Daiichi Sankyo’s Merck & Co. – partnered antibody-drug conjugate (ADC) patritumab deruxtecan has been rejected by the FDA. Prior to this, it was to be Merck’s first ADC launch and the first HER3 drug to enter the market. The FDA’s response was due to issues that surfaced during an inspection of a contractor's manufacturing facility rather than any problems with safety or efficacy data. The rejection of HER3-DXd happened shortly after a phase 1 trial of its competing HER3-targeted ADC was put on a partial clinical hold because of the death of three patients.
In view of co-developing and co-commercializing, Merck paid Daiichi $4 billion in autumn 2023 for HER3-DXd as one of its ADC assets. Patritumab deruxtecan caused a tumor shrinkage rate of 29.8% in the HERTHENA-Lung01 trial, with a median duration of response that lasted 6.4 months in EGFR-mutated NSCLC patients, progressing after chemotherapy and a tyrosine kinase inhibitor. One death related to the drug was reported, caused by the acknowledged side effect of Daiichi’s DXd technology – interstitial lung disease.
For years Daiichi has invested in internal ADC production capabilities, starting with a 15-billion-yen investment to build and refurbish manufacturing lines at the company’s plants in Japan in 2017. Still, Daiichi has been considering outside manufacturers and revealed a $1.1 billion (1 billion euro) investment to expand its Pfaffenhofen site in Germany. Aside from the ability to manufacture cardiovascular disease drugs, ADCs are an important factor in this expansion.
Sanofi has requested private equity bids for its consumer health unit, Bloomberg. Buyout bids were asked to be provided by interested parties by mid-July 2024. The most keen private equity firms are thought to be PAI Partners (Paris) and Advent International (Boston), while Blackstone (US), Clayton (US), TPG, (US) Dubilier & Rice, (US) CVC Capital Partners (Luxembourg) are also vying. The unit is valued at approximately $20 billion.
Sanofi announced in October 2023 that they aimed to make an independent company in the last quarter of the year 2024, with headquarters in Paris. A capital markets transaction was believed to be the most probable avenue to complete the separation, as in the new company, Sanofi could retain a notable minority stake. In 2023, Sanofi’s consumer unit produced $5.6 billion (5.2 billion euros) in sales, constituting 11% of the total revenue of the company.
In an effort to focus on its specialties of immunology treatments and vaccines, Sanofi’s plans to divest follow similar decisions by other companies, such as Novartis, Pfizer, and Johnson & Johnson, to give increased attention to the development and commercialization of prescription drugs.
In a phase 3 trial, Gilead’s HIV PrEP drug has reported no infections. The result emerged from the PURPOSE 1 trial assessing Gilead Sciences’ twice-yearly, subcutaneous lenacapavir in adolescent girls (ages 16 to 25) and women in Uganda and South Africa. The capsid inhibitor Lenacapavir has been previously approved by the FDA under the brand name Sunlenca to treat HIV along with other antiretroviral drugs.
The trial involved more than 5,300 people across 28 different sites who received lenacapavir, or otherwise Gilead’s daily oral PrEP drugs Descovy or Truvada. Zero infections were recorded during the trial period among over 2,000 women from the lenacapavir group, but the Truveda group recorded an incidence of rate of 1.69 per 100 person-years and the Descovy group 2.02 per 100 person-years.
The Gilead medication performed noticeably better on the trial’s primary endpoint, which compared lenacapavir to a background incidence rate of 2.41 per 100 person-years. Additionally, the medication outperformed the secondary comparator Truvada.
Merck’s Capvaxive (formerly V116), the first pneumococcal disease vaccine designed for adults, has been approved by the FDA, setting it up to become the primary vaccine to prevent the bacterial infection in seniors. The 21 serotypes Capvaxive covers make up 84% of the pneumococcal disease of patients aged 50 or over. Pfizer’s Prevnar 20 has a 52% figure in the same population for the 20 serotypes covered by the vaccine, which can be given to both adults and children. Nonetheless, no studies have been undertaken to compare the efficacy of Prevnar 20 and Capvaxive.
Four phase 3 trials supported the approval of Capvaxive, with one trial demonstrating V116’s superiority in 10 of its 11 idiosyncratic serotypes and non-inferiority in the 10 serotypes in each vaccine.
The expedited approval for Capvaxive is still pending confirmation of clinical benefit in a confirmatory study. The CDC will convene the Advisory Committee on Immunisation Practices (ACIP) on June 27th to deliberate recommendations about the administration of Capvaxive.
Pfizer’s phase 3 gene therapy trial has failed to improve motor function for boys with Duchenne muscular dystrophy (DMD). This unfortunate result comes after the recent death of a boy from cardiac arrest in May 2024 after participating in the related phase 2 trial DAYLIGHT which involved 2 to 3 year-old boys with DMD. Including ambulatory boys between the ages of 4 and 7, the phase 3 DMD trial, also known as CIFFREO, is a double-blind study assessing an experimental recombinant adeno-associated virus gene therapy termed fordadistrogene movaparvovec.
The pharmaceutical company has now disclosed that, as compared to placebo at one year of therapy, CIFFREO did not meet its primary target of enhancing motor function, as measured by the North Star Ambulatory Assessment movement scale. Important secondary goals, including time to rise and 10-meter run/walk velocity, did not show a significant difference between fordadistrogene movaparvovec and placebo either.
According to Pfizer, the phase 3 trial's overall safety profile for the gene therapy was manageable, with the majority of adverse events being mild to moderate in nature. According to a press release from the company on 12th June 2024, major adverse events connected to treatment were typically receptive to clinical management. Pfizer is currently assessing the best course of action for the program and will keep monitoring participants.
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