Novartis’s breast cancer SERD tumbles after Phase I/Ib termination

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Novartis’s breast cancer SERD tumbles after Phase I/Ib termination

Novartis’s breast cancer SERD tumbles after Phase I/Ib termination

GlobalData’s Investigative News team reviews data generated by an in-house model that combines machine learning and its proprietary algorithm. Likelihood of Approval (LoA) provides the probability of a drug in securing market authorization; Phase Transition Success Rate (PTSR) indicates the probability of a drug advancing to the next stage of development. The model uses data points from individual drugs, clinical trials, regulatory milestones, company, and financial databases.To get more novartis latest news, you can visit shine news official website.

Novartis’s selective ER antagonist and degrader (SERD), LSZ102, had its PTSR dive by 33 points to 40% in ER-positive Her2-negative breast cancer. This is on the back of a Phase I/Ib LSZ102 trial termination. The Phase I/Ib (NCT02734615) was terminated by Novartis, the trial’s sponsor, according to an 11 October update posted on ClinicalTrials.gov. The PTSR was appraised the next day (12 October).

The trial investigated the oral LSZ102 as a monotherapy or in combination with Novartis’s own Kisqali (ribociclib) or Piqray (alpelisib) in patients with oestrogen receptor-positive (ER+) breast cancer who have progressed after endocrine therapy. Due to the Phase I/Ib termination, LSZ102’s LoA also dropped by six points to 7%.

On 25 August, primary endpoint safety data was reported, showing LSZ102 was well tolerated as a monotherapy and with Kisqali, and had a manageable safety profile with Piqray. Preliminary LSZ102 clinical activity was also seen with the combination, particularly with Kisqali.
Johnson Johnson’s (JJ) positive Phase IIb results for its RSV vaccine propelled the candidate ahead in its development journey with a 15-point rise in its PTSR. Its LoA also rose by 5 points edging to 15%.

On 2 October, the company announced the positive results where the trial met its primary and secondary endpoints as part of a late-breaking abstract at the virtual ID Week conference. The vaccine displayed an 80% efficacy rate in preventing RSV-associated lower respiratory tract disease in adults who are 65 years or older. The PTSR for the vaccine stands at 52%, as of 5 October.
The Phase IIb (NCT03982199) CYPRESS study evaluated a combination of the company’s investigational vaccine candidate Ad26.RSV.preF with a prefusion F (preF) protein designed to induce a more optimal response.

Based on signals seen in that trial, JJ launched a Phase III trial (NCT04908683) that will enroll approximately 23,000 adults who are 60 years and older at different sites across North America, Europe, Asia and the Southern Hemisphere. The vaccine has a Breakthrough Therapy designation for the prevention of lower respiratory tract disease caused by RSV in adults who are 60 years or older.
Enanta Pharmaceuticals’ farnesoid X receptor (FXR) agonist EDP-305 had its PTSR drop by 11 points to 42% in nonalcoholic steatohepatitis (NASH). On 4 October, the company announced it no longer plans to continue further internal development, and it will instead prioritize combination approaches via an outlicensing strategy for the asset. The same decision was made with its other FXR agonist EDP-297.

EDP-305’s PTSR was updated on 5 October. As a result of the company decision, the Phase IIb ARGON-2 trial (NCT04378010) studying EDP-305 monotherapy is discontinued, the announcement states. Based on available data from its ARGON development program, the 1mg EDP-305 dose provided the best balance between tolerability and efficacy. On the back of Enanta’s update, EDP-305’s LoA also dropped by 2 points to 6%.

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