The American Society of Clinical Oncology’s annual meeting kicks off this week in Chicago, the largest and most high-profile oncology conference. It also marks a return to in-person gatherings following ASCO’s virtual meetings for the past two years due to Covid-19 (though many will also be offered online). This year’s conference has more than 2,800 abstracts spread across more than 200 presentations. Here are some key pieces of information on our radar.
Mirati tries to catch Amgen in KRAS
last year, Amgen Receives FDA Accelerated Approval for Lumakras, a Drug Targeting Rare KRAS G12C Mutation in patients with non-small cell lung cancer. Mirati Therapeutics is pursuing the same goal with its drug adagrasib, while the biotech is Detailing clinical trial results support its submission to the FDA. A regulatory decision is expected in mid-December.
Mirati plans to showcase at ASCO Data from the pivotal clinical trial of adagrasib on Friday. The phase 2 study enrolled 116 patients with NSCLC showing the KRSA G12C mutation. The objective response rate was 42.9%, and the median duration of response was 8.5 months. In the Lumakras pivotal study, results showed an objective response rate of 36% and a median duration of response of 10 months. Two years of data look better. At last month’s annual meeting of the American Association for Cancer Research, Amgen Report The objective response rate was 40.7%, and the median duration of response was 12.3 months. Mirati said the safety profile of its drug was consistent with earlier studies; the most common treatment-related adverse reactions were gastrointestinal problems and fatigue.
Non-small cell lung cancer can metastasize or spread to the brain, and Mirati’s report includes Phase 1b data evaluating adagrasib in active, untreated CNS metastases. The presentation is scheduled for June 6th. An investor event is scheduled for the evening.
Amgen’s data discussions at ASCO include Summary analysis From Codebreak 100, which is evaluating the mechanisms of resistance that KRAS G12C cancers can acquire. This analysis was designed to provide insights into Lumakras combination therapy.
Redeem Roche?
The prospects for Roche’s TIGIT-blocking drug tiragolumab have dimmed after the drug failed in two recent clinical trials. Earlier this month, the company reported a lack of information when it reported a recent failure of a non-small cell lung cancer treatmentBut without providing details, Roche pointed to numerical improvements and upcoming overall survival data, another major goal of the study.
Tiragolumab is under scrutiny because Bristol-Myers Squibb, GlaxoSmithKline and Gilead Sciences are pursuing the same goal. Roche’s failure could affect the rest of the field. Details of the first Phase 3 failure of tiragolumab are scheduled to be released on June 5. Meanwhile, the pharma giant has turned to touts the prospect of another drug, glofitamab, being tested in an aggressive blood cancer. T cell binding bispecific antibody positive Data from the pivotal Phase 2 study Support for regulatory submissions.
At ASCO, Roche’s Genentech division will present data from a pivotal Phase 2 study testing glofitamab in patients with advanced diffuse large B-cell lymphoma who did not respond to a median of three prior therapies. Bispecific antibodies are designed to bind to two targets, one on cancer cells and the other on T cells. Glofitamab is designed with two regions that bind to CD20 on B cells and CD3 on T cells of cancer cells.
Genentech said data from the Phase 2 extension study showed durable complete responses after a median follow-up of 12.6 months. Complete responses, the primary efficacy endpoint, were reported in 39.4% of patients; of those who demonstrated complete responses, 77.6% had responses that were durable and sustained at 12 months. The most common adverse event occurred in 63% of patients and was cytokine release syndrome. Data have been submitted to the European Medicines Agency. A submission to the FDA and other agencies is planned later this year. The drug is also in clinical development to support an earlier route to the drug as a treatment for lymphoma.
Sierra to show full data on drugs that led to M&A deals
GlaxoSmithKline struck a big cancer drug deal last month, agreed $1.9 billion for Sierra Oncology and its FDA-ready myelofibrosis drug momelotinibAt ASCO, Sierra will present the full Phase 3 clinical trial data, showcasing what has piqued the pharma giant’s interest.
Myelofibrosis is a blood cancer in which dysregulated signaling in the bone marrow leads to inflammation and fibrosis that impair the production of red blood cells. Momelotinib is a small molecule designed to block two JAK enzymes and a third, ALK2, at the root of signaling dysregulation. Sierra claims its drug is the first and only JAK inhibitor to show positive clinical data in myelofibrosis, spleen size and symptoms of anemia.
in January, Preliminary data reported by Sierra shows that 25% of patients treated with its drug achieved primary goals The control group was 9% as measured by myelofibrosis symptom assessment.Full efficacy and safety data from this study will be Submitted June 7th.
Adicet’s update on off-the-shelf CAR T therapies
Adicet Bio will provide from Phase 1 Study Test ADI-001, the biotech’s off-the-shelf CAR T-cell therapy for advanced B-cell non-Hodgkin lymphoma. Allogeneic cell therapy is made from a type of immune cell called gamma delta T cells, which are rarer than the alpha beta T cells used in many other cell therapies but have the potential to last longer. last December, Adicet reports preliminary Phase 1 data providing some validation for the approachAt ASCO, the company will report updated data that further builds the drug’s case.
a sofa February 14 deadline, of the four patients who achieved complete remission after treatment with ADI-001, two continued to achieve complete remission at three months or longer follow-up. Safety data are consistent with previous reports. A summary of the detailed safety and efficacy data as of the deadline of February 14 is now available. Data with a deadline of May 31 will be presented at ASCO on June 6.
Photo: espiegle, Getty Images
