Healthcare & Life Sciences News & Trends: Dec Week 2

i. Trials and Market Approval

i. Merck Advances ADC to Phase 3 Following 100% Complete Response Rate

Merck & Co. is advancing its ROR1-directed antibody-drug conjugate (ADC), zilovertamab vedotin, into a phase 3 trial following promising phase 2 results in diffuse large B-cell lymphoma (DLBCL). Key highlights include:

• Clinical Efficacy: The ADC demonstrated a 100% complete response rate in the low-dose cohort (1.75 mg/kg), with comparable results at higher doses but with some discontinuations due to adverse events.
• Safety Profile: Serious treatment-related adverse events (TRAEs) occurred in 58% of patients, including neutropenia, nausea, anaemia, and diarrhoea, though none were fatal or directly tied to the ADC.
• Phase III focus: Merck’s phase 3 trial aims to improve outcomes over the current standard of care (R-CHOP) by potentially offering broader and more durable responses.

Takeaway: With relapse rates of 10%-25% in existing treatments, zilovertamab vedotin could address unmet needs in a space.

ii. Imfinzi Bags FDA Approval as the First Immunotherapy Regimen for LS-SCLC

AstraZeneca received FDA approval for its PD-L1 inhibitor, Imfinzi. The approval is for a new indication in treating adult patients with limited-stage small cell lung cancer (LS-SCLC) who have not experienced disease progression after concurrent platinum-based chemotherapy and radiation. In the ADRIATIC Phase III trial, Imfinzi significantly improved overall survival, with the treatment group achieving 55.9 months compared to 33.4 months in the placebo group, a remarkable 22.5-month increase.

Takeaway: This marks a breakthrough in the LS-SCLC field, which has seen limited progress for over 30 years. It also makes Imfinzi the first and only immunotherapy option for LS-SCLC worldwide. AstraZeneca’s expansion into lung cancer treatment is further reinforced by its development of several innovative therapies, including:

• EGFR-targeted treatments;
• China’s first MET inhibitor, savolitini;
• China’s first PD-L1 inhibitor, durvalumab;
• Dato-DXd, which is expected to become the first TROP2-targeted ADC in NSCLC.

Concurrently, AstraZeneca has developed a proprietary pathology platform, Quantitative Continuous Scoring (QCS), which uses AI to quantify the biomarker TROP2 to guide ADC therapy accurately. The platform is being developed in partnership with Roche, with plans to turn it into a companion diagnostic product that would support the market launch of Dato-DXd when approved.

The company is also making strides in immune bispecific therapies, with its PD-1/TIGIT and PD-1/CTLA-4 demonstrating efficacy and safety in high and low-expressing metastatic NSCLC patients.

2. Business Moves

i. Daiichi Sets Up $152m ADC Plant in China as Enhertu Secures National Coverage

Daiichi Sankyo is investing ¥1.1 billion to establish its first ADC manufacturing facility in Shanghai, which will be operational by 2030. This move follows the inclusion of Enhertu, its AstraZeneca-partnered HER2-targeting ADC, in China’s updated National Reimbursement Drug List (NRDL). Concurrently, Daiichi’s second ADC, datopotamab deruxtecan, is also under regulatory review in China.

Takeaway: Daiichi’s investment signals a long-term commitment to the Chinese market. Besides increasing its production capacity, Daiichi’s expansion plan also places increasing focus on oncology, with new labs and manufacturing capabilities for ADCs.

ii. Bausch + Lomb Confirms Intent to Sell

Bausch + Lomb, a leading provider of eye care products, is exploring a potential sale as part of its broader efforts to separate from its parent company, Bausch Health Companies. This development comes under CEO Brent Saunders, a seasoned dealmaker who returned to lead Bausch + Lomb in early 2023. Saunders has a history of executing high-profile M&A deals, including the sale of Allergan to AbbVie for $63 billion and leading Valeant’s $8.7 billion buyout of Bausch + Lomb in 2013.

Takeaway: If completed, the buyout could be one of the largest private equity healthcare deals of the year, with an estimated enterprise value of $13 – $14 billion.

3. People Moves

Amgen: Three Amgen executives will be stepping down:

• Irene Hsu: Hsu, the departing Vice President and General Manager for China, took over the role of General Manager for Amgen China from Meiling Ke three years ago. Hsu previously held senior leadership roles in multinational pharmaceutical companies such as Janssen and Roche across various regional markets.
• Harry Wu: Wu, the departing Head of Amgen China’s Cardiovascular Business Unit, previously served as the Head of Central Nervous System Diseases at Novartis China and has held roles at Merck and Pfizer. In 2019, he successfully launched Repatha® (evolocumab) in China, the country’s first approved PCSK9 inhibitor.
• Eddie Fan: Eddie Fan is the Head of Amgen China’s Bone Health Business Unit and has led Amgen to its present status as a pioneer in the osteoporosis market with the successful 2020 launch of Prolia® (denosumab) in China.

Amgen has initiated internal and external recruitment processes to identify their successors as soon as possible. Amgen’s Asia Pacific General Manager, Meiling Ke, will serve as the Interim General Manager for Amgen China.

EuroAPI: EuroAPI, a Sanofi spin-off specialising in active pharmaceutical ingredients (APIs) and contract development and manufacturing (CDMO), is undergoing significant leadership changes amid a major restructuring. The company has made two appointments:

• COO David Seignolle was named the new CEO, succeeding Ludwig de Mot, who served briefly after his appointment in February 2024.
• Emmanuel Blin, a former Bristol Myers Squibb executive, was named board chair.

These leadership transitions come as EuroAPI pursues strategic goals to streamline its API portfolio and focus on CDMO.

Acadia: Acadia Pharmaceuticals appointed 25-year pharma veteran Thomas Andrew Garner as CCO.

• Experience: Garner previously served at Lexicon Pharmaceuticals, where he spearheaded the relaunch of the heart failure drug Inpefa (sotagliflozin). He also held roles at BMS, Boehringer Ingelheim and Eli Lilly.
• Focus: He will focus on strengthening Acadia’s established drug Nuplazid. He will also drive the growth of its newer offering, Daybue, and oversee its ongoing US launch and preparations for international rollouts.

Acadia’s pipeline also includes late-stage candidates like ACP-101 for hyperphagia in Prader-Willi syndrome and ACP-204 for Alzheimer’s disease psychosis.

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Image Credits:

• Daichii Sankyo