Vepdegestrant

All of the regular ASCO abstracts dropped Thursday afternoon, with the biggest news coming from the VEGF bispecific race , Merck and Kelun-Biotech’s TROP2 ADC known as sac-TMT, and multiple head and neck cancer updates . But there were plenty of other developments across cancer trials and new mechanisms, and we’ve rounded up the best of the rest here. Find updates below on potential successors for Pfizer’s blockbuster Ibrance, the Tubulis data that got Gilead Sciences excited enough to buy it out, and more. Both Pfizer and BeOne Medicines (formerly BeiGene) are developing CDK4 inhibitors in a bid to take up Ibrance’s mantle in breast cancer, as the first Ibrance biosimilars are expected as soon as next year. For Pfizer, the successor is called atirmociclib. The drugmaker toplined a separate Phase 2 success earlier this year in HR-positive, HER2-negative breast cancer, but an abstract released Thursday supplemented those results. Patients received either a combination of atirmociclib and an aromatase inhibitor called letrozole, or letrozole alone. Efficacy was measured with an endpoint called “complete cell cycle arrest,” or CCCA, which examines how quickly patients’ tumor cells stopped dividing. After 14 days, 45 of 51 patients (88.2%) who took the combination regimen saw their cell division slow by a meaningful amount, compared to 10 of 56 (17.9%) who only received letrozole. The data come from patients with advanced breast cancer who progressed after treatment with a CDK4/6 inhibitor (including Ibrance). Pfizer enrolled patients whose tumor cells were dividing rapidly. BeOne, meanwhile, is researching a program called BGB-43395 and reported data from a safety expansion cohort of a Phase 2 study, also looking at a combination with letrozole. The company has enrolled 58 patients so far across three dosing regimens. After a median follow-up of 6.8 months, the median time-to-response was 3.6 months and progression-free survival was not reached. Unlike these experimental drugs, Ibrance is a CDK4/6 inhibitor. Global Ibrance sales peaked in 2022 with $5.12 billion. In 2025, Ibrance was selected for the second round of price negotiations under the Inflation Reduction Act, with new prices expected to be implemented for patients with Medicare starting next year. Gilead paid $3.15 billion upfront last month to acquire the ADC-focused biotech Tubulis, and an ASCO abstract released Thursday attempts to show why. The biotech’s lead program is called TUB-040, a NaPi2b-directed ADC that is in testing for certain forms of ovarian cancer and non-small cell lung cancer. Tubulis administered the drug to patients with platinum-resistant ovarian cancer across four dose levels in a Phase 1/2a study, 46 of whom could be evaluated for efficacy. Of those 46 patients, 28 saw their tumors shrink by at least 30%, good for a confirmed objective response rate of 60.9%. Responses were spread almost evenly across all dose levels, with seven patients responding in each of the two lowest doses, eight responding in the third level and six responding at the highest dose. Gilead and Tubulis initially signed a partnership in 2024 before this year’s buyout. Gilead could pay another $1.85 billion if all milestones in the deal are met. Earlier this month, the FDA approved Pfizer and Arvinas’ drug vepdegestrant (brand name: Veppanu) for patients with a certain form of breast cancer. But it’s unclear how many patients will take it, and the companies shipped the drug’s rights to Rigel Pharmaceuticals for $70 million upfront — a fraction of the $1 billion Pfizer initially paid for the partnership. Data released Thursday from a Phase 1b/2 study continued to illustrate why the drug has disappointed. In second-line patients with certain ER-positive/HER2-negative breast cancers, Veppanu plus an aromatase inhibitor induced responses in just eight of 33 patients at the highest dose measured (24.2% confirmed ORR). Only five of 31 who received the low dose responded to the therapy. Response rates were lower in patients with ESR1 mutations, with three of 14 patients (21.4%) responding to the high dose. These mutations are where the expected competition of oral SERDs has largely been a success. Pfizer and Arvinas presented Phase 3 data for the drug at last year’s ASCO, showing it was no better than oral SERDs. AstraZeneca’s B7-H4 ADC: The drug is called puxitatug samrotecan, or puxi-sam. At its low dose, 14 of 31 patients with endometrial cancer (34.1% ORR) and four of 33 with ovarian cancer (12.1% ORR) saw their tumors shrink by at least 30%. At the high dose, 24 of 50 endometrial cancer patients (48% ORR) and 11 of 45 individuals with ovarian cancer (24.4% ORR) saw the same level of tumor shrinkage. Median PFS in endometrial cancer was 8.1 months and seven months at the high and low doses, respectively. In ovarian cancer, median PFS was 5.7 months at the high dose and 4.8 months at the low dose. Additionally, the company released very early data from a cohort looking at patients with biliary tract cancer. After a median follow-up of 2.2 months, two of 20 patients saw their tumors shrink by at least 30%, good for an ORR of 10%. The company hopes more patients will respond after longer periods of time. Immuneering posts more pancreatic cancer results: The biotech rolled out another update for its oral MEK inhibitor atebimetinib, after multiple positive updates in the last 12 months measuring it in combination with chemotherapy. After a median follow-up of 10.4 months, median PFS was 8.4 months and median overall survival was not reached among 50 patients. Six- and nine-month OS rates were 88% and 79%, respectively. AstraZeneca’s Neogene data: The first data from AstraZeneca’s 2022 buyout of Neogene were released Thursday, showing results from the NT-175 program in patients with TP53 mutations in solid tumors. Investigators said 10 of 21 patients who received the therapy responded after a median six months of follow-up. This included five of six patients with pancreatic cancer who took part in the study. NT-175 is an autologous engineered T-cell receptor (eTCR) T cell therapy. Replimune’s three-year survival rates: The company’s therapy RP1, which was rejected twice by the FDA , achieved a three-year OS rate of 45.5% in patients with advanced melanoma. Patients got RP1 along with the anti-PD-1 drug Opdivo after previously failing anti-PD-1 therapy.

Rigel gets hands on Pfizer's recently-approved breast cancer drug Bayer cuts early-stage assets from pipeline Superior weight loss in Wegovy HD early responders 'First-of-its-kind' collab aims to incubate new biotechs Rigel gets hands on Pfizer's recently-approved breast cancer drug Having signalled their intent last year to find a US commercialisation partner for vepdegestrant, Pfizer and Arvinas reached an agreement with Rigel Pharmaceuticals on Tuesday to both market and further develop the PROTAC oestrogen receptor (ER) degrader. The deal comes a matter of weeks after the FDA approved the oral drug as Veppanu for ER-positive, HER2-negative, advanced or metastatic breast cancer in adults carrying ESR1 mutations and who have progressed after at least one line of endocrine therapy (see – Spotlight On: Uncertain future resolved for Pfizer and Arvinas' once heavily touted breast cancer drug as Rigel steps in). Under the agreement, Pfizer and Arvinas will receive $85 million in upfront and transition payments, with the potential for a further $320 million in development, regulatory and commercial milestones, plus tiered sales royalties in the mid-teens to mid-20s. All payments from Rigel will be split evenly between the two companies. Pfizer itself had paid Arvinas $650 million upfront in 2021 to co-develop and co-commercialise vepdegestrant, but subsequent clinical readouts narrowed the addressable patient population. For its part, Rigel will own global rights to vepdegestrant, allowing it to sublicense the therapy to potential partners for development and marketing outside of the US. -Matt Dennis Bayer cuts early-stage assets from pipeline As part of its first-quarter earnings report Tuesday, Bayer disclosed that it has cut two Phase I programmes from its pipeline and halted development of Verquvo (vericiguat) in adults with stable chronic heart failure (CHF) and reduced ejection fraction (HFrEF). In September, the pharma, alongside partner Merck & Co., reported that the sGC stimulator — approved in the US and EU for certain patients with worsening CHF — failed to meet its primary endpoint in a Phase III trial for HFrEF. The axed early-stage assets include BAY 2701250, an atrial natriuretic peptide (ANP)-based candidate that was in Phase I testing for pulmonary hypertension. According to ClinicalTrials.gov, the 82-person study finished last May. The third cut programme is BAY 3178275, a Phase I-stage GPR84 antagonist being developed for diabetic neuropathic pain.-Elizabeth Eaton Superior weight loss in Wegovy HD early responders New sub-analyses from the pivotal STEP UP trial show Novo Nordisk's 7.2-mg semaglutide injectable formulation (marketed as Wegovy HD) resulted in a ~28% weight loss among 'early responders' — outclassing the 20.7% reduction originally seen in the wider study. Data presented Tuesday at the European Congress on Obesity (ECO) revealed that early responders — defined as those achieving ≥15% body weight loss within 24 weeks — accounted for 27% of Wegovy HD recipients, compared with 21% for the 2.4-mg dose and 3% on placebo. Novo said that the early responders on Wegovy HD lost on average 27.7% of their weight by week 72, versus. Moreover, a separate MRI sub-analysis with STEP-UP confirmed that 84% of weight lost was attributable to fat mass reduction, including a >30% decrease in abdominal visceral fat, with muscle function largely preserved. For further analysis, see — Spotlight On: Early responder analysis could be useful catalyst for Wegovy HD in US obesity showdown. -Pavan Kamat 'First-of-its-kind' collab aims to incubate new biotechs In what is being touted as a "first-of-its-kind" collaboration, life sciences investment firm Delos Capital is partnering with biopharmaceutical company AP Biosciences to create and incubate new biotechs. The tie-up combines Delos' company-building expertise with APBio's antibody discovery platforms in an effort to accelerate novel medicines through clinical proof of concept. The collaboration will also take advantage of APBio's operational efficiency in Greater China, which the parties noted enables "faster and more capital-efficient translation from innovative concepts to clinical-stage assets." The companies will initially focus on autoimmune diseases using bi- and tri-specific antibody approaches that combine novel and de-risked targets and mechanisms, with Delos — through its Delos Foundry — leading therapeutic ideation, financing and strategic development. "This collaboration allows us to extend the impact of our antibody discovery platforms beyond our internal pipeline," said Jeng Her, APBio's chief executive. Meanwhile, Henry Chen, founder and managing partner of Delos noted that "if we don't see existing companies that match one of our investment theses, our team can fill that gap by incubating innovative assets in a US-based NewCo." -Matt Dennis The content above comes from the network. if any infringement, please contact us to modify.