Replies to post #246405 on Biotech Values

[DewDiligence]

More on mRNA-1427 from Evaluate Vantage:

https://www.evaluate.com/vantage/articles/events/conferences-trial-results/aacr-2023-more-hope-modernas-neoantigen

December’s toplining of the first ever positive results from a controlled trial of a cancer immunotherapy, Moderna’s mRNA-4157, caused jubilation [#msg-170681303, #msg-170681207]. The group’s valuation gained $15bn, and the news validated Merck & Co’s earlier $250m bet on the project.

But was the enthusiasm warranted? The answer, after full data from the Keynote-942 trial in adjuvant melanoma were unveiled at AACR today, seems to be: maybe.

…At AACR it was revealed that the RFS rates at 18 months were 78.6% for the immunotherapy combo [i.e. mRNA-1427 + Keytruda], versus 62.2% for Keytruda alone. Severe adverse events occurred in 25% versus 18% of patients respectively…

…The RFS result cut at 12 months came out at 77% for control and 83% for Keytruda plus mRNA-4157…

…Moderna said a phase 3 melanoma trial would begin soon, with studies in "lung cancer and beyond" also planned.

Until today, all that was known about this trial's efficacy was that the HR for DFS was 0.56 with a 1-sided p-value of 0.027.

[swampboots]

Yes ADNX Neo travails were notable and connected with the fate for the neoantigen platform not yet pronounced ,in line with the current summed up scientific literature of that platform, featuring obstacles yet to be resolved at that time (for any future bio company continuing with that neoantigen platform).

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=144624521

[DewDiligence]

MRNA/MRK report_updated phase-2b data_for mRNA-4157 cancer vaccine in_resected_Stage-III/IV melanoma:

https://www.accesswire.com/870288/moderna-merck-announce-three-year-data-for-mrna-4157-v940-in-combination-with-keytruda-pembrolizumab-demonstrated-sustained-improvement-in-recurrence-free-survival-distant-metastasis-free-survival-versus-keytruda-in-patients-with-high-risk-stage

• At a median planned follow-up of the Phase 2b study at 34.9 months, mRNA-4157 (V940) in combination with KEYTRUDA reduced the risk of recurrence or death by 49% and the risk of distant metastasis or death by 62% compared to KEYTRUDA alone in these patients

• The 2.5-year recurrence-free survival rate of mRNA-4157 (V940) in combination with KEYTRUDA was 74.8% as compared to 55.6% for KEYTRUDA alone, with the benefit observed across exploratory subgroups

• The companies have initiated Phase 3 studies in patients with high-risk melanoma and non-small cell lung cancer, in addition to Phase 2 studies in patients with renal cell carcinoma and urothelial carcinoma and a Phase 2/3 study for cutaneous squamous cell carcinoma

MRK/MRNA reported in Dec 2022 that this phase-2b trial (KEYNOTE-942) met its primary endpoint of DFS with an impressive HR of 0.56 (#msg-170681303). The companies reported even better data (HR=0.51) in Apr 2023 after a median follow-up of 23-24 months (#msg-171699261, #msg-171699374). The data reported today are based on the same patient pool approximately one year later (median follow-up of 35 months) with HR for DFS remaining 0.51.

MRNA says the FDA may consider mRNA-4147 for accelerated approval in melanoma based on the above phase-2b data when MRNA’s new manufacturing facility for this product in Marlborough, MA comes online.