Register Log-in Investor Type

Trust favourite Genmab hit by trial setback

Trust favourite Genmab hit by trial setback

Trust favourite Genmab hit by trial setback

Denmark’s Genmab, a widely-held stock among the sector specialist investment trusts, has suffered a major setback in the past week with failure/termination of studies involving its lead product Darzalex, which is sold by Johnson & Johnson. The studies were both aimed at expanding the range of uses of Darzalex, which is already approved for multiple myeloma (MM), to include in combinations with anti-PD-1 antibodies in MM and as well as in solid tumours.

Genmab’s shares fell by around 20% on the news, which will undoubtedly hit the performance of Swiss-listed HBM Healthcare (HBMN) and London-listed International Biotechnology Trust (IBT), both of which held the company – Europe’s largest quoted biotech – within their top 10 holdings, equivalent to 2-3% of NAV. Baillie Gifford-managed Edinburgh Worldwide Trust (EWI), a large generalist fund with significant exposure to biotech, also had a holding, albeit proportionally smaller at ~1% of its NAV.

Genmab reported at the weekend that a Phase Ib/II study of Darzalex plus Tecentriq (Roche’s anti PD-L1 antibody) vs Tecentriq alone in patients with previously treated non-small cell lung cancer (NSCLC) would be terminated, following a planned review by the trials’s independent data monitoring committee (DMC). The DMC determined that there had been no observed additional benefit in the combination treatment arm over monotherapy while there was a numerical increase in mortality-related events. Furthermore, based on the findings, J&J decided to discontinue a separate study evaluating the combination of Darzalex and its own anti-PD-1 antibody (JNJ-63723283) in MM.

A key element in the consensus view on Genmab’s prospects was the potential to expand Darzalex’s use from haematological (blood based) cancers such as MM into solid tumours. This now looks to be in serious doubt. Darzalex is nevertheless already successful in MM and consensus sales are forecast to reach $6bn/year by 2024. Genmab has important readouts approaching in the form of the Maia and Cassiopeia trials, whose results are due later this year.

Darzalex remains in many studies designed to explore solid tumour indications, including Phase II trials in combination with Opdivo (Bristol-Myers Squibb’s anti-PD1 antibody) for colon cancer, triple negative breast and pancreatic cancer, and virus -associated cancers, the outcome of which will be important to determine whether there is additional activity to be gained.

Meanwhile, Merck & Co is planing a Phase II study in combination designed to explore the potential of its anti-PD-1 antibody Keytruda in combination with Darzalex in relapsed/refractory MM, which may have to be reviewed in the light of J&J’s decision over its similar study.

The news came after the failure of a Phase III study designed to expand the uses of a different Genmab-developed product, Arzerra, which is approved for chronic lymphocytic leukemia (CLL) and sold by Novartis. The study tested Arzerra plus bendamustine vs bendamustine alone in patients with indolent B-cell non-Hodgkin’s lymphoma (iNHL) who were unresponsive to rituximab or a rituximab-containing regimen and failed to show a benefit for the combination.

Leave a Reply

Your email address will not be published. Required fields are marked *

Please review our cookie, privacy & data protection and terms and conditions policies and, if you accept, please select your place of residence and whether you are a private or professional investor.

You live in…

You are a…