ASH: Sanofi, Johnson & Johnson on collision course with Sarclisa, Darzalex 4-drug regimens in myeloma

Sanofi and Johnson & Johnson further fuel their CD38 rivalry between Sarclisa and Darzalex in multiple myeloma. With approvals already in place as triple therapies, both companies now touting early clinical victories for four-drug regimens.

In newly diagnosed multiple myeloma transplant-eligible patients, the addition of Sarclisa by Sanofi to a widely used regimen of Bristol Myers Squibb’s Revlimid, Takeda Velcade, and corticosteroid dexamethasone (RVd) helped further patients achieve very low levels of minimal residual disease (MRD) in the bloodstream after induction therapy.

Although not the trial sponsor, Sanofi has worked closely with the German speaking group Myeloma Multicenter Group (GMMG) and “it is possible that Sanofi is working on a deposit plan with GMMG in the future” , Zsuzsanna Devecseri, Head of Sanofi’s Global Medical Oncology Department. business, told Fierce Pharma via email. An October presentation shows that the French pharmaceutical company expects to potentially file Sarclisa for approval in newly diagnosed transplant-eligible myeloma based on GMMG in 2024 or beyond.

In the study, 50.1% of patients treated with the Sarclisa combo achieved MRD negativity, while this was the case for 35.6% of RVd patients, which means that the patients who received Sarclisa were 83 % more likely to reach this marker. MRM is a well-established marker for measuring the effectiveness of treatment and a fairly good prognostic factor for predicting clinical outcome.

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The data comes from the GMMG-HD7 trial and marks the first time that a Phase 3 study has reported a better rate of MRD negativity after induction of a CD38 antibody in addition to RVd, the investigators noted. The results are presented at the 63rd annual meeting of the American Society of Hematology.

But the trial was not entirely positive. On a secondary endpoint, the complete response rates were similar between the two arms. Devecseri argued that the end of induction is usually too early to detect a significant difference in complete response rates, because the removal of the myeloma protein takes some time.

On the Johnson & Johnson side, the company is providing longer-term follow-up for Darzalex’s RVd combo in newly diagnosed transplant-eligible multiple myeloma in the phase 2 Griffin trial. After induction and consolidation therapy, the trial now has two years of data on maintenance therapy.

At this assessment point, the Darzalex-RVd combo maintained a 64.4% higher MRD negativity rate versus 30.1% for RVd, according to data released at ASH 2021. Full response rates have deepened. at 82% for the Darzalex regime after two years of maintenance, against 61% for the RVd.

Darazlex-RVd has also improved sustainable customs clearance rates. Among MRM-negative patients, 44% in the Darzelex-RVd group had this status for at least one year, compared to 13% for RVd.

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Craig Tendler, global head of late clinical development in hematology and oncology at J & J’s Janssen, said he was not surprised by Sarclisa’s MRD after induction. But it really is a sustained rate of MRD negativity that indicates better treatment outcomes for patients, he noted in an interview.

In another show that gives Tendler more confidence in the ongoing Phase 3 trial dubbed Perseus of Darzalex in the same context is an increasingly pronounced trend towards improved disease progression for quadruplicate therapy. Although not statistically significant for a small phase 2 trial, Darzalex-RVd reduced the risk of progression or death by 54% compared to RVd after a median follow-up of 38.6 months.

While this dataset for the CD38-RVd combos comes from trials conducted in a transplant-eligible population, the two CD38 antibodies are also set to face a final showdown in patients who are not. not eligible for transplantation.

There, phase 3 of Darzalex Cepheus the trial previously had a primary completion date of April. An independent data monitoring committee conducted a review at that time and recommended that the trial continue to follow patients, with the next analysis scheduled for 2022, Tendler said.

As for Sarclisa, its phase 3 Imroz study for the RVd-Sarclisa couple was to be read this year. But Sanofi recently adjusted the schedule and now expects to have data in the first half of next year.

Darzalex is more than four years ahead of Sarclisa. The drug Janssen is approved in several combination treatment regimens for different indications, including newly diagnosed myeloma. Sarclisa marked Sanofi’s comeback in oncology with a first green light from the FDA last March, but it does not yet have a frontline label.

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