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Monday, December 11, 2023

ASH: Legend patient-reported outcome data from Phase 3 CARTITUDE-4 study

 

  • In CARTITUDE-4, CARVYKTI® demonstrated clinically meaningful improvements in patient-reported outcomes when compared to standard of care
  • The as-treated population in CARTITUDE-4 demonstrated strong rates of progression-free survival and overall response
  • Longer-term data from CARTITUDE-2 showed deep and durable responses in earlier lines of treatment among patients in Cohort A and Cohort B

Harpoon Phase 1 Data in Relapsed/Refractory Multiple Myeloma (RRMM) at ASH

 

  • HPN217 was well tolerated and demonstrated robust and durable clinical activity at doses ranging from 2.15 to 24 mg in heavily pre-treated patients, including patients with prior exposure to BCMA-targeted therapy
  • At the 12 mg dose, cohorts demonstrated favorable activity and safety profile:
    • 63% ORR; with 53% VGPR or better
    • CRS reported in 16% of patients, no Grade 3 events, no ICANS
  • Findings support further clinical development at the 12 mg RP2D

Kite’s Yescarta® CAR T-Cell Therapy Support Curative Potential in Non-Hodgkin Lymphomas

  • ZUMA-1 Post-Hoc Analysis Shows Five-Year Lymphoma-Related Event-Free Survival in a Substantial Proportion of Patients with Refractory Large B-cell Lymphoma
  • Four-Year Follow-up from ZUMA-5 Demonstrates Continued Durable Response and Long-Term Survival in Patients with Relapsed/Refractory Follicular Lymphoma
  • ZUMA-7 Overall Survival Subgroup Analysis in Patients Aged 65+ Shows that Age Alone is not a Barrier to Receiving CAR T

Gracell Updated Data on Deep and Durable Responses in Newly Diagnosed Multiple Myeloma

 

  • Minimal residual disease negativity (MRD-) observed in all treated patients in the ongoing study, with 95% (21/22) achieving stringent complete response (sCR) through a median follow-up of 18.8 months
  • GC012F is a FasTCAR-enabled B-cell maturation antigen (BCMA) and CD19 dual-targeting autologous CAR-T therapy being evaluated for hematologic malignancies and autoimmune disease

Lilly: Updated Data from Phase 1/2 in Chronic Lymphocytic Leukemia and Mantle Cell Lymphoma

  Eli Lilly and Company (NYSE: LLY) today announced updated clinical data from the international Phase 1/2 BRUIN trial of pirtobrutinib, a non-covalent (reversible) Bruton's tyrosine kinase (BTK) inhibitor, in adult patients with a range of B-cell malignancies. These data, which were presented in oral and poster presentations at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition, continue to support the role of pirtobrutinib in the treatment of chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) and mantle cell lymphoma (MCL).

"With longer follow-up, we continue to observe efficacy and tolerability data that support the potential utility of pirtobrutinib in CLL and B-cell lymphomas in the post-covalent BTK inhibitor setting," said Matthew S. Davids, M.D., M.M.Sc., Dana-Farber Cancer Institute. "These data demonstrate the ability of pirtobrutinib to potentially lengthen the time patients may benefit from inhibiting BTK, a key target in these diseases. It is also encouraging to see the promising initial data for pirtobrutinib combined with venetoclax, which has the possibility to allow for a time-limited regimen for patients with CLL."

"Following the two FDA accelerated approvals for pirtobrutinib in 2023, we are excited to present these data at ASH, further building the body of evidence for this medicine in CLL, SLL, MCL, and other B-cell malignancies," said David Hyman, M.D., chief medical officer, Lilly. "These data support the potential role that pirtobrutinib, the first and only FDA-approved non-covalent BTK inhibitor, can play in extending the time patients may benefit from BTK inhibition therapy and provide additional efficacy data in patients previously treated with a covalent BTK inhibitor. We look forward to expanding our understanding of the broader potential clinical utility of pirtobrutinib as we continue to progress our series of randomized Phase 3 studies in CLL, SLL, and MCL."

J&J CARVYKTI Improves QOL, Reductes Symptoms in Earlier-Line Multiple Myeloma

 Oral presentations at the 2023 ASH Annual Meeting include patient-reported outcomes from the CARTITUDE-4 study and longer-term efficacy and safety data from CARTITUDE-2 study cohorts A and B, show the promise of CARVYKTI® in earlier lines of treatment

https://www.biospace.com/article/releases/treatment-with-carvykti-ciltacabtagene-autoleucel-resulted-in-clinically-meaningful-improvements-in-health-related-quality-of-life-and-reductions-in-disease-specific-symptoms-in-patients-with-earlier-line-multiple-myeloma/

UK's Sunak defends government's handling of pandemic, restaurant scheme

 Prime Minister Rishi Sunak defended Britain's handling of the COVID-19 pandemic on Monday, telling an official inquiry he did not recognise testimony describing a dysfunctional government and saying his hospitality scheme was supported at the time.

The inquiry is examining Britain's response to the pandemic which killed more than 230,000 people in the country. It has heard that the government of then-prime minister Boris Johnson was gripped by infighting and incompetence, and unable to make a decision.

Sunak was a relatively unknown politician when he was promoted to finance minister on the eve of the pandemic, appearing to be sure-footed as he set out hundreds of billions of pounds of support to keep companies and livelihoods afloat.

He has come under fire during the inquiry so far from other witnesses over his "Eat out to help out" subsidised meal scheme, which encouraged people to visit restaurants and pubs in August 2020.

Some scientists have questioned whether Sunak's policy may have contributed to a wave of infections, but Sunak said scientists and other ministers did not raise any objections during meetings in the month leading up to the scheme.

He said that "Eat out to help out" took place within guidelines for the safe re-opening of hospitality which had happened in July and that was why the policy went ahead.

"My primary concern was protecting millions of jobs of particularly vulnerable people who worked in this industry (hospitality)," Sunak told the inquiry.

The inquiry has also heard testimony from scientists and officials who questioned whether Sunak prioritised the economy over public health, as economic output contracted by 10% in 2020.

He told the inquiry on Monday that he wanted to say how "deeply sorry" he was to those who had lost loved ones, and that he was there in the spirit of wanting to learn how the government could do better in any future pandemic.

But he echoed Johnson in saying the fact that "debates raged" was not necessarily a bad thing.

"It's right that there was vigorous debate because these were incredibly consequential decisions for tens of millions of people in all spheres, whether it was health, whether it's education, whether it was economic, whether it was social, whether it was a long-term impact.

"These were incredibly big decisions, the likes of which no prime minister has taken in decades, if ever," he said.

Sunak became prime minister in October 2022 after Johnson and his successor Liz Truss were forced out of office.

https://news.yahoo.com/uks-sunak-tells-covid-inquiry-110648595.html