ESMO Reaction
September 15, 2022

ESMO Reactions: CodeBreaK 200

ESMO Reaction
September 15, 2022

ESMO Reactions: CodeBreaK 200

Author

Sotorasib versus docetaxel for previously treated non-small cell lung cancer with KRAS G12C mutation: CodeBreaK 200 phase III study.

Abstract #LBA10: Melissa L. Johnson presented the primaryanalysis of the P3 CodeBreaK 200 trial. The trial compared sotorasib (n=169) vs docetaxel(n=151) in KRAS G12C-mutated NSCLC patients who progressed after prior platinum-based chemotherapy and a checkpoint inhibitor.

Results: Met primary endpoint of a statistically significant improvement in PFS with sotorasib vs docetaxel. One-year PFS was 24.8% vs 10.1% forsotorasib vs docetaxel, respectively. Met key secondary endpoints:Sotorasib significantly improved ORR (28.1% vs 13.2%) and DCR (82.5%vs 60.3%) vs docetaxel. OS was not significantly different between treatment arms, though the trial was not powered for OS. Sotorasib had fewer Grade ≥3 AEs than docetaxel (33.1% vs 40.4%).

Thought leader opinions on these results are mixed.While the trial met its primary endpoint, many thought leaders consider sotorasib’s benefit in this trial modest

Several commentators were disappointed by the poor OSbenefit and felt it may prompt reimbursement challenges given the expense of this targeted therapy.

A few oncologists indicated that the trial provided no meaningful information, as sotorasib was already SOC in this patient population. Docetaxel is not preferred by physicians and there are other approved combination treatments that improve OS in this patient population.

Oncologists wanted to understand if observed toxicity was due to previous treatment or to sotorasib. Detailed guidelines for AE management were requested.

Summary: Preliminary data from the CodeBreaK 200 trial shows that sotorasib provides significant PFS, ORR, and DCR benefit over docetaxel with fewer AEs. However, thought leaders largely consider these results disappointing, as sotorasib was expected to perform better – for instance, no OS benefit was demonstrated. In addition, there are widespread concerns surrounding toxicity and cost.

Synthesis by Opus Strategy, LLC

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Not rated
Allison Betof Warner, MD, PhD (she/her) 4
3743
Manhattan, NY
November 10, 2022

79% had reduction in disease. ORR 31%. Many responses deepen over time.

Not rated
Allison Betof Warner, MD, PhD (she/her) 3
3743
Manhattan, NY
November 10, 2022

Median DOR not yet reached. Median OS 13.9 mo. 12 mo OS was 54%. As typical with immunotherapy, we see a nice tail on the curve. #TIL#SITC22

Positive
Alex Shoushtari, MD
2253
New York, USA
November 10, 2022

Important work on efficacy of TIL therapy lifileucel in PD-1 resistant #melanoma being presented at #SITC22. Pretty good durability for this heavy lift of a treatment.

Not rated
Allison Betof Warner, MD, PhD (she/her) 2
3743
Manhattan, NY
November 10, 2022

Toxicity profile was in line with prior TIL/Lifileucel data. No surprises here. Median # doses of IL-2 was 6.

Positive
Hussein Tawbi, MD, PhD
1685
Houston, TX
November 10, 2022

Absolutely agree!… this should be available to our melanoma patients ASAP!… and paves the way for smarter cellular therapies to be designed, studied, and eventually widely disseminated

Positive
Allison Betof Warner, MD, PhD (she/her) 1
3744
Manhattan, NY
November 10, 2022

Where does this leave us with #TIL therapy for #melanoma? IMO, this response rate/durability justifies accelerated approval. Pts with PD-1 refractory melanoma need options. It’s FAR from a perfect tx but provides meaningful clinical benefit. What say you melanoma Twitterverse?

Not Rated
Sumanta K. Pal, MD, FASCO
15083 Followers
Los Angeles, CA
November 8, 2022

Just before I start AM clinic at @cityofhopeoc, excited to share results from #COBALT_RCC, a P1 trial of @CRISPRTX#CTX130 in #kidneycancer in the @sitcancer#PressProgram. Will present more on Thurs 5:37p at #SITC22! Thx @neerajaiims@DrBenTran@HaanenJohn#SamerSrour& co-Is! t.co/aDnhG9n92A

not rated
Shilpa Gupta
5095 Followers
Cleveland, OH
November 8, 2022
Not Rated
Tian Zhang, MD, MHS
6463 Followers
Dallas, TX
November 8, 2022

CAR-Ts are coming for #kidneycancer!! Congratulations @montypal and team; can’t wait to see results at #SITC22! t.co/9MrlF2yzBe

Not Rated
Moshe Ornstein MD
1930 Followers
Cleveland, OH
November 8, 2022

Congrats @montypal and team! Great to see CAR T therapy coming to #RCCt.co/ypRHBC89Pt

Not Rated
Shuchi Gulati MD
12476 Followers
Seattle, WA
November 8, 2022

Another huge step from none other than @montypal!! CAR-Ts in #kidneycancer!Congratulations to the entire team!Looking forward to seeing the results at #SITC22! t.co/HvKeVBPyV7

Not Rated
Petros Grivas
12476 Followers
Seattle, WA
November 8, 2022

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