JJ

[JJ @Cancerdoc2001]

@DmitryKovalchuk also look at the follow ups

[JJ @Cancerdoc2001]

@dr_yakupergun @stolaney1 if the HR for PFS2 is getting worse than PFS, it means that the control arm patients did better on subsequent line of therapy vs the experimental arm; PFS2 (contrary to what some believe) is sum of PFS + PFS on subsequent line rather than PFS on subsequent line of treatment

[JJ @Cancerdoc2001]

@JacobPlieth The design, as described, doesn’t make sense (based on current standard of care)

[JJ @Cancerdoc2001]

@hoperugo @SuyogCancer @drsarahsam @dr_yakupergun @elmayermd @myESMO You indeed did; also the inadequate power and post study therapies confounding the OS was well explained

[JJ @Cancerdoc2001]

@drsarahsam financial and emotional toxicity without any evidence of clinical benefit

[JJ @Cancerdoc2001]

@adamfeuerstein @PersimmonTI Exactly; I recall the same happened for Avastin in frontline GBM. PFS significant but OS negative and it was an ASCO plenary

[JJ @Cancerdoc2001]

@JacobPlieth @AppleHelix All drugs approved in this setting have shown OS benefit

[JJ @Cancerdoc2001]

@drsarahsam For a strategy like this, OS benefit is critical. There was no cross-over or access to post study SERD that could have confounded the OS result

[JJ @Cancerdoc2001]

@lifebiomedguru @SenTimKaine The most balanced and scientific explanation of the issue

[JJ @Cancerdoc2001]

@PTarantinoMD @OncBrothers None; AI alone

[JJ @Cancerdoc2001]

@hoperugo @SuyogCancer @OncoAlert depends what the patients had access to post-progression

[JJ @Cancerdoc2001]

@JacobPlieth @ByMadeleineA @ApexOnco any comments on the control arm Jacob??

[JJ @Cancerdoc2001]

@calliecoombsmd Only 5 patients at risk at the median PFS timepoint

[JJ @Cancerdoc2001]

@Myeloma_Doc Hi Rob…my understanding was that they compared triplet (len-dara-2 cycles of dex) vs doublet (len and continuous dex)

[JJ @Cancerdoc2001]

@gurgavin I liked the earlier pic

[JJ @Cancerdoc2001]

@drjohnm @oncology_bg @WSJ @VPrasadMDMPH not approved in this population (without ESR1 mutation)

[JJ @Cancerdoc2001]

@JacobPlieth @ApexOnco something called selection bias

[JJ @Cancerdoc2001]

@SuyogCancer 100% CDK4/6 experienced vs other trials; only other trial with this population is elacestrant phase 3, which had a similar outcome for fulvestrant

[JJ @Cancerdoc2001]

@Myeloma_Doc Encouraging ORR; granted this is a heavily pretreated population, however, would have expected a better PFS