Tamibarotene

The SELECT-MDS-1 trial showed no significant difference in CR rates between tamibarotene/azacitidine and placebo/azacitidine (23.8% vs. 18.8%, p=0.2084). Tamibarotene/azacitidine was generally well-tolerated. Syros plans to stop the study, review data, and evaluate next steps due to the trial's failure to meet its primary endpoint, constituting an event of default under its loan facility.

The SELECT-MDS-1 trial found tamibarotene plus azacitidine did not significantly improve CR rate over azacitidine alone in HR-MDS patients with RARA overexpression. The CR rate was 23.8% vs 18.8%, not statistically significant. The combination was generally well-tolerated. Syros Pharmaceuticals will discontinue the trial and review data.

Syros Pharmaceuticals' phase III study for tamibarotene in MDS missed primary endpoint; Amgen's stock steady despite analyst report; Adaptimmune reports positive results for lete-cel; Daiichi Sankyo and Astrazeneca submit new BLA for lung cancer treatment; Apollo Therapeutics signs $938 million deal with Sunshine Lake Pharma; study identifies quiescent cancer stem cells in glioblastoma relapse; Modifi Biosciences acquired by Merck for up to $1.3 billion.

Syros Pharmaceuticals' stock declines sharply as its Phase III trial with lead cancer therapy, tamibarotene, fails to meet primary endpoint in higher-risk myelodysplastic syndrome patients. This follows a similar outcome in a Phase II trial for acute myeloid leukaemia, leading to a 76% drop in stock. The trial's failure also constitutes a default event under Syros' secured loan facility with Oxford Finance.

Syros Pharmaceuticals’ phase III failure with tamibarotene in MDS led to stock damage and potential acceleration of a $43.6 million loan obligation.

Syros’s Phase III myelodysplastic syndrome trial with tamibarotene failed, despite analysts’ hope that a prior negative result in acute myeloid leukemia would not affect it.

Recent breakthroughs in myelodysplastic syndromes (MDS) include the VERONA and SELECT-MDS-1 trials, potentially shifting MDS treatment. FDA actions in October 2024 included approvals for acalabrutinib, priority review for Enhertu, and Cologuard Plus launch. DESTINY-Breast06 shows Enhertu's potential in HER2-low/ultra-low breast cancer. KEYNOTE-522 demonstrated improved survival with pembrolizumab in early-stage triple-negative breast cancer. LEAP-012 showed significant PFS improvement with lenvatinib/pembrolizumab in intermediate HCC. The 19th Annual NY Lung Cancers Symposium will focus on early-stage lung cancer treatment strategies.

Syros Pharmaceuticals' Q3 2023 report highlights $0 million revenue, $26.2 million operating expenses, and a $6.4 million net loss. The company advances tamibarotene for HR-MDS and AML, with SELECT-MDS-1 trial enrollment complete and pivotal CR data expected in mid-November 2024. Syros realigned its strategy, reducing employee base by 35% and discontinuing SELECT-AML-1 trial. The company faces substantial doubt about its ability to continue as a going concern, needing additional capital for operations.