- Amgen preps for another advisory board.
- Sorrento announces promising findings in solid tumor CAR-T cell therapy.
- G1 Therapeutics's CDK inhibitor could be a big deal.
Note: Subscribers to Avisol Capital Partners Total Pharma Tracker got an early look at this publication.
Welcome to another edition of "3 Things In Biotech You Should Learn Today," a daily digest dedicated to helping you keep pace with the fast-moving world of pharmaceutical and biotechnology research.
Amgen preps for another advisory board
Company: Amgen (AMGN)
Disease: Acute lymphoblastic leukemia
News: AMGN received the briefing documents from the FDA regarding their upcoming FDA ODAC meeting on March 7 to discuss their application for the treatment of minimal residual disease-positive acute lymphoblastic leukemia. This board will discuss the strength of the data supporting the application, in addition to laying out potential concerns regarding efficacy and safety in this treatment setting. In particular, the briefing documents saw concerns in the 2% rate of treatment-related fatalities, as well as flaws in the propensity analysis used to compare blinatumomab to historical controls.
Looking forward: While the ODAC concerns are important, I think they will ultimately not sink this particular application. There were some issues relating to heterogeneity of the population in the study and the outcomes therein, but blinatumomab appeared to establish a fairly clear benefit as far as non-randomized studies can, and the risk of sepsis was reduced compared with other patients with relapsed/refractory ALL.
Overall, be cautiously optimistic about AMGN's chances here, and note that an approval would make a big difference in the blinatumomab franchise.
Sorrento announces promising findings in solid tumor CAR-T cell therapy
Company: Sorrento Therapeutics (SRNE)
Therapy: Anti-CEA CAR-T cells
Disease: Liver metastases
News: SRNE announced initial results from their phase 1b HITM-SURE study, investigating their CAR-T cell therapy directed against carcinoembryonic antigen (CEA) in patients with relapsed CEA-positive liver metastases. The three patients who have completed the protocol achieved an average reduction of 19 ng/mL of the antigen, providing an early indication that the therapy is working as intended. One of the patients, who has stage IV pancreatic cancer, had no evidence of liver metastasis at 11 months based on a PET scan.
Looking forward: These findings build on the inch-by-inch momentum SRNE has gained in this particular space. CEA has long been used as a potential marker of tumors like pancreatic cancer, and it's good news that there is an early sign of addressing this often-fatal complication of cancer. Considering the strong unmet need here, it's hard not to give this news a thumbs up, even though it's very early days still.
For now, I would definitely not consider buying on this news alone, but it makes me want to pay attention to SRNE.
G1 Therapeutics's CDK inhibitor could be a big deal
Company: G1 Therapeutics (GTHX)
Disease: Small cell lung cancer
News: GTHX announced positive top-line data from a phase 2a trial investigating the addition of their CDK4/6 inhibitor trilaciclib to standard chemotherapy (etoposide/cisplatin) for patients with treatment-naive small cell lung cancer. Safety was the key readout here, as patients in the trilaciclib arm had a 67.5% reduction in the rate of grade 3/4 hematologic adverse events, and the risk of neutropenia in particular was cut in half through the addition of trilaciclib. There was no significant difference in efficacy readouts, although there were trends toward favorable duration of response and PFS in the trilaciclib arm.
Looking forward: This news came as a big surprise to me, given the fact that for the three approved CDK4/6 inhibitors, neutropenia is perhaps the most important side effect, and it is serious enough with palbociclib and ribociclib that patients can't receive it continuously. But here, we have an agent with the same mechanism of action that actually protects against chemotherapy-induced neutropenia? That's remarkable, even if the efficacy findings weren't staggeringly successful.
This puts GTHX on my radar for sure now, and I am very curious to learn more about them.
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