ASCO 2022 ahead: Clinical trial updates and data readouts to watch for

ASCO 2022 ahead: Clinical trial updates and data readouts to watch for

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The annual meeting of the American Society of Clinical Oncology kicks off in Chicago this week, the largest and most closely watched of oncology conferences. It also marks a return to an in-person gathering following ASCO’s virtual meetings for the past two years due to Covid-19 (though many of the sessions will also be available online). This year’s conference features more than 2,800 abstracts scattered across more than 200 presentations. Here’s a look at some key ones on our radar.

Mirati vies to catch Amgen in KRAS

Last year, Amgen won accelerated FDA approval for a Lumakras, a drug targeting a rare KRAS G12C mutation in patients with non-small cell lung cancer. Mirati Therapeutics is pursuing the same target with its drug adagrasib, and the biotech is detailing the clinical trial results supporting its submission to the FDA. A regulatory decision is expected by mid-December.

At ASCO, Mirati is scheduled to present data from adagrasib’s pivotal clinical trial on Friday. The Phase 2 study enrolled 116 patients whose NSCLC exhibited the KRSA G12C mutation. The objective response rate was 42.9% and the median duration of response was 8.5 months. In Lumakras’s pivotal study, results showed a 36% objective response rate and a 10-month median duration of response. The two-year data look a bit better. During the American Association for Cancer Research annual meeting last month, Amgen reported that 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 frequent treatment-related adverse effects were gastrointestinal problems and fatigue.

Non-small cell lung cancer can metastasize or spread to the brain and Mirati’s presentations include Phase 1b data evaluating adagrasib in active, untreated central nervous system metastases. This presentation is scheduled for June 6. An investor event is scheduled for that evening.

Amgen’s data discussions at ASCO include pooled analysis from Codebreak 100, which is evaluating the resistance mechanisms that KRAS G12C cancers can acquire. This analysis is intended to offer insights into combination treatments with Lumakras.

Redemption for Roche?

Prospects for Roche’s TIGIT-blocking drug tiragolumab dimmed in the wake of that drug’s two recent clinical trial failures. Information was scant when the company reported the most recent failure in non-small cell lung cancer earlier this month. But without providing details, Roche pointed to numerical improvements as well as a forthcoming data readout on overall survival, the other main goal of the study.

Tiragolumab is under close watch because Bristol Myers Squibb, GlaxoSmithKline, and Gilead Sciences are among the companies that are also pursuing the same target. A failure for Roche could affect the rest of the field. Details from tiragolumab’s first Phase 3 failure are scheduled to be presented on June 5. Meanwhile, the pharma giant has turned to touting the prospects of a different drug, glofitamab, which is being tested in an aggressive type of blood cancer. The T-cell engaging bispecific antibody has positive data from a pivotal Phase 2 study that supports regulatory submissions.

At ASCO, Roche’s Genentech unit will present data from a pivotal Phase 2 study testing glofitamab in patients whose advanced diffuse large B-cell lymphoma had not responded to a median three prior therapies. Bispecific antibodies are designed to bind to two targets, one on a cancer cell and the other on a T cell. Glofitamab is engineered with two regions that bind to CD20 on cancerous B cells and CD3 on T cells.

Genentech said data from a Phase 2 expansion study show durable complete responses after a median follow-up of 12.6 months. Complete responses, the main efficacy endpoint, were reported in 39.4% of patients; of those who showed a complete response, 77.6% of them had responses that were durable and ongoing at 12 months. The most common adverse event, occurring in 63% of patients, was cytokine release syndrome. Data have already been submitted to the European Medicines Agency. Submissions to the FDA and other agencies are planned for later this year. The drug is also in clinical development to support use of the drug as an earlier line of lymphoma treatment.

Sierra to show full data for drug that led to M&A deal

GSK struck a big cancer drug deal last month, agreeing to pay $1.9 billion for Sierra Oncology and its FDA-ready myelofibrosis drug, momelotinib. At ASCO, Sierra will unveil the full Phase 3 clinical trial data showing what caught the interest of the pharmaceutical giant.

Myelofibrosis is a type of blood cancer in which dysregulated signaling in the bone marrow leads to inflammation and fibrosis that impairs red blood cell production. Momelotinib is a small molecule designed to block two JAK enzymes at the root of the dysregulated signaling as well as a third enzyme, ALK2. Sierra claims its drug is the first and only JAK inhibitor demonstrating positive clinical data on the symptoms of myelofibrosis, spleen size, and anemia.

In January, Sierra reported preliminary data showing that 25% of those treated with its drug met the main goal as measured according to a myelofibrosis symptom assessment compared to 9% in the control arm. The full efficacy and safety data from the study will be presented on June 7.

Adicet update on off-the-shelf CAR T therapy

Adicet Bio will present data from a Phase 1 study testing ADI-001, the biotech’s off-the-shelf CAR T cell therapy, as a treatment for advanced B-cell non-Hodgkin’s lymphoma. The 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 of the other cell therapies, but offer the potential to last longer. Last December, Adicet reported preliminary Phase 1 data lending some validation to the approach. At ASCO, the company will report updated data further building the drug’s case.

As of a Feb. 14 cut-off date, of the four patients who achieved a complete response following treatment with ADI-001, two continued to have a complete response with three months of follow-up or longer. Safety data were consistent with the earlier report. An abstract detailing safety and efficacy data as of the Feb. 14 cutoff is available now. Data from a May 31 cutoff date will be presented at ASCO on June 6.

Photo: espiegle, Getty Images

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