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Sanofi's Darzalex rival scores in myeloma trial

Antibody first to show benefit in combination setting

Sanofi

Sanofi’s bid to grab a slice of the multiple myeloma market has advanced thanks to a positive phase 3 trial of isatuximab in relapsed/refractory patients with the blood cancer.

Top-line results from the ICARIA-MM trial reveal that the CD38-targeting antibody was able to prolong progression-free survival (PFS) when added to a standard myeloma regimen of Celgene’s Pomalyst/Imnovid (pomalidomide) and low-dose dexamethasone.

According to Sanofi, this is the first time that an antibody drug has been shown a benefit when added to pomalidomide and dexamethasone for treatment of relapsed/refractory myeloma. The study is one of four phase 3 trials being conducted by the French drugmaker to support regulatory filings for isatuximab in both second- and first-line myeloma treatment, starting later this year.

If approved, isatuximab would compete in the market with Johnson & Johnson and Genmab’s anti-CD38 antibody Darzalex (daratumumab), which was first approved in 2016 as a fourth-line treatment and has seen its sales explode as it has steadily moved up the treatment pathway, claiming first-line approval last year.

Darzalex has been a massive success in myeloma, with sales reaching more than $2bn last year, a rise of 63% on 2017, thanks to a favourable toxicity profile and high activity alone or in combination with other drugs.

Sanofi has something of a mountain to climb with isatuximab, with no clear sense yet of how its drug compares with the market leader, although it has suggested it has a shorter infusion time. In the meantime, additional anti-CD38 competition is looming from the likes of MorphoSys with MOR202 and Takeda with TAK-079, both in mid-stage testing, while J&J and Genmab are also developing a subcutaneous formulation of daratumumab that could make dosing easier.

Another rival is Bristol-Myers Squibb and AbbVie’s Empliciti (elotuzumab), which targets SLAMF7 rather than CD38 which was approved for the relapsed/refractory patient population in 2015 in combination with Celgene’s Revlimid (lenalidomide) and dexamethasone. Last year, the two partners reported positive mid-stage data with a Pomalyst/dexamethasone combination.

Sanofi was a big player in oncology in the 1990s, but has been playing catch-up in the cancer arena in the last few years. It is a late entrant into the immuno-oncology category with its Libtayo (cemiplimab) checkpoint inhibitor, approved by the FDA for cutaneous squamous cell carcinoma last September, although the availability of that drug could provide an opportunity for isatuximab.

"We are excited by these results, which represent significant progress in our ambition to extend the lives of multiple myeloma patients," said John Reed, who has been at the helm of Sanofi's R&D efforts since last April. "We look forward to engaging with regulatory authorities with the goal of bringing this potential new treatment to patients as quickly as possible."

John Reed

Sanofi's John Reed

Libtayo and isatuximab are being tested by Sanofi as a combination for myeloma, an indication which hasn’t been addressed by other checkpoint inhibitors, as well as solid tumours.

The company will present its Q4 and full year results for 2018 on Thursday. Key developments for the company this year include the market development of Cablivi, which is approved in the EU and awaiting a final FDA nod, as well as the expected approval of insulin add-on Zynquista (sotagliflozin).

Article by
Phil Taylor

5th February 2019

From: PME

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