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CRC updates from GI23: Drs. Eng, Saeed, Smith & Sanford

Doc Talks

GI23, the American Society of Clinical Oncology’s GI Oncology-focused meeting, just finished in San Francisco this January.

In the DocTalk below, broken into four parts, Paltown Scientific Director Dr. Manju George chats with Dr. Cathy Eng, Dr. Anwaar Saeed, Dr. J Joshua Smith, and Dr. Nina Niu Sanford about CRC updates from this meeting. 

Part 1: Dr. Cathy Eng

In part one, Dr. Cathy Eng covers a few interesting results, including a poster on the effect of dropping the 5FU bolus, some results on neoadjuvant therapy for MSS colon cancer, rare subsets of metastatic CRC like those with BRAF mutations & HER2/ERBB2 amplification. Lastly, she talks briefly about new results on the use of ctDNA in colorectal cancer.

Part 2: Dr. Anwaar Saeed

Dr. Anwaar Saeed covers a few interesting #GI23 results including the Agenus Bot+Bal trial & its safety profile, RIN trial, IO+TKI trial such as STELLAR 303, other IO+ approaches, a general intro to adoptive cell therapy including engineered TCRs & CART cell approaches. She covered TMB and its use as an IO biomarker. She also talked about machine learning and its use in CRC.

Part 3: Dr. Nina Niu Sanford

In part three, Dr. Nina Sanford covers a few interesting results including those from NRG GI-002, OPERA & RAPIDO trials & goes over ongoing questions with regard to Total Neoadjuvant Therapy.

Part 4: Dr. J Joshua Smith

In part four, Dr. J Joshua Smith talks about rectal cancer results from #GI23. The last part has Q & A covering many topics.

Q & A

Q1: I would like to hear the news in ASCO 2023 regarding KRAS g12c

Dr. Eng: Phase II/III data still pending.

I would like to get data regarding the combo with shp2 or with immunotherapy

Dr. Eng: I am unaware of the Phase I data being reported out yet with SHP2 or with immunotherapy at this time. The AACR meeting is in April, there may be some data reported there. The combo are historically completed with EGFR inhibitors as well.

Q2: Any data regarding TIL or TCR for CRC?

Answered in the session

Q3: Excited about FRESCO-2 results. Regarding sitting with FDA for approval. Any ideas on what that means generally on timeline…are we talking months or years?

Dr. Eng: Hopefully in the next few months. It will be submitted for FDA and EMA and Japanese approval.

Q4: The question I had sent in was for Dr. Josh Smith “can you explain the rectal cancer research at ASCO GI23 regarding Tumor Deposits and EMVI.

The speaker at ASCO was saying may be more important than the current staging system looking at lymph nodes… and that rectal cancer spreads through blood vs lymph nodes.”

Is that a matter of debate among experts? Answered in the session in Part 4

Q5: Is the Mountaineer FDA approval in the 2nd line for mCRC? Or 1st line as well?

Dr. Eng: Mountaineer tucatinib will only be approved for previously treated. Newly dx’d will be asked to participate on Mountaineer3

Q6: Do you think SUNLIGHT will turn into approval in the EU?

Dr. Eng: SUNLIGHT will result in approval in EU and that is the point of the study design. Won’t impact us in the US.

Q7: Is Leucovorin always recommended with 5-FU?

Answered in the session

Q8: Do you think the broad findings on ctDNA for stages II-IV, apply to Stage IV – stats like the probability of recurrence, etc.?

Dr. Eng: ctDNA is best in stage III and stage IV vs. stage I and II based on prior studies

Q9: SUNLIGHT: with ~75% of pts having had prior bev, is the data able to be stratified to see the difference?

Answered in the session

Q10: will the rego+ipi+nivo work on peri mets?

Answered in the session

Q11: But for the CAMILLA trial there were responses in liver mets for some KRAS WT pts, correct?

Answered in the session

Q12: will TIL work for mucinous adeno?

Answered in the session

Q13: Is anti-PDL1 indicated for immunotherapy for CRC?

Answered in the session

Comment: Further support re: TMB as biomarker? Dr Fakih’s RegoNivo analysis saw no diff in response of TMB >5 vs. <5

Q14: The Grade 3 AE’s from RIN seem to be higher re: liver issues than I recall re: typical tx. Is this something being seen in other IO/combo trials as well?

Answered in the session

Q15: Do autoimmune diseases such as hypothyroidism exclude you from IO therapy?

Answered in the session

Q16: For the Agenus trial… what is the best way for patients on the trial to deal with any colitis AEs?

Dr. Eng: Yes, the trial is built in now with the recommended medication to reduce the incidence of colitis.

Dr. Sanford: Fucoidan sounds so much fancier than brown seaweed.

Q17: Assuming brown seaweed isn’t expensive, would you support a pt who wanted to take it?

Dr. Sanford: Yes, I think so.

Q18: Can radiation therapy be considered for mets to ovaries (possibly Krukenberg) if resection is not possible? if so, are there any papers supporting this?

Dr. Sanford: Yes, they can technically. Would do if RT makes sense in clinical context (i.e. if few mets/oligomet disease)

Q19: For the Janus trial, do you think low risk Stage II patients will be motivated to enroll?

Answered in the session

Q20: Does data from the Camilla trial indicate that liver met patients had some success?

Dr. Saeed: Yes, there were some liver metastasis patients that responded to cabozantinib plus durva in the Camilla trial

Q21: Should I get a hormone sensitivity test on my tumor tissue if I want to continue with my Premarin cream?

Answered in the session

Q22: How do you see using ctDNA in Watch & Wait scenarios… or in looking at current rectal cancer trials?

Answered in the session

Q23: It seems that the discussion on organ preservation often gets poorly simplified to an ostomy vs. no ostomy, but someone at ASCOGI (I can’t remember who) included the breadth of QOL impacts which were much broader. What is the best reference regarding understanding the full picture better?

Answered in the session

Q24:Will JANUS trial be expanding from MSKCC & Univ of FL soon?

Answered in the session

Q25: Is it a good idea to always remove the primary tumor even when it’s responded well to FOLFOX and now not seen as a bowel wall thickening on CT?

Answered in the sessio