AstraZeneca

The FDA approved Fasenra based on the MANDARA Phase III trial, showing its efficacy and safety in EGPA patients, with nearly 60% achieving remission and 41% tapering off oral corticosteroids.

PD-1 inhibition with pembrolizumab before and after surgery significantly improves 5-year overall survival (86.6% vs 81.7%) in high-risk early triple-negative breast cancer, according to KEYNOTE-522 trial results.

Enhertu (trastuzumab deruxtecan) demonstrated significant overall and intracranial clinical activity, including prolonged PFS, in HER2-positive mBC patients with brain metastases in the DESTINY-Breast12 trial. The findings support Enhertu's potential as a second-line treatment, with a 12-month PFS rate of 61.6% and CNS PFS rate of 58.9% among patients with brain metastases.

Daiichi Sankyo and Merck's antibody-drug conjugate, patritumab deruxtecan, met Phase 3 trial goals, delaying EGFR-mutated non-small cell lung cancer progression better than chemotherapy. The drug uses an antibody to target tumor cells and release a toxic chemical. Daiichi has six ADCs using deruxtecan chemotherapy, including Enhertu, with sales of $1.8 billion in H1 2024. Merck's $22 billion deal with Daiichi aims to bolster its pipeline as Keytruda patents near expiration.

FDA approves Sanofi and AstraZeneca's new filling line for Beyfortus, enabling expanded manufacturing capacity and supply in the U.S. for the 2024/2025 RSV season. Beyfortus, a long-acting antibody, was FDA-approved in July 2023 for infants and children up to 24 months old at severe risk of RSV infection. CDC analysis in March 2024 showed Beyfortus 90% effective at preventing RSV hospitalization.

Solid tumors market projected to reach $375.4B by 2034 with 7.45% CAGR. Aethlon Medical activates Hemopurifier trial at Royal Adelaide Hospital for solid tumor patients resistant to anti-PD-1 therapies. Immuneering reports positive initial data for IMM-1-104 in pancreatic cancer. FDA approves new immunotherapy combinations for endometrial cancer from AstraZeneca, Merck, and GlaxoSmithKline. Roche's trastuzumab deruxtecan receives accelerated approval for HER2-positive solid tumors.

The NIAGARA study showed AstraZeneca's Imfinzi improved event-free survival in muscle-invasive bladder cancer, with a 25% reduction in death risk. This contrasts with Bristol Myers Squibb's Opdivo, which was previously approved for adjuvant use. The FDA's cautious stance on perioperative studies may delay Imfinzi's approval, despite its potential impact. Other ongoing trials, like KEYNOTE-866 and VOLGA, aim to further evaluate immunotherapies in this setting.

HIMALAYA trial results show AstraZeneca’s Imfinzi plus Imjudo reduced HCC death risk by 24% at 5 years, with 19.6% survival vs 9.4% with sorafenib.

AstraZeneca's Phase III HIMALAYA trial of Imfinzi (durvalumab) plus Imjudo (tremelimumab) showed a 24% reduction in death risk in advanced liver cancer patients, with 19.6% surviving five years, compared to 7% historically.